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Tuesday, 13 March 2012

Temomedac 140mg hard capsules

1. Name Of The Medicinal Product

Temomedac 140 mg hard capsules

2. Qualitative And Quantitative Composition

Each hard capsule contains 140 mg temozolomide.

Excipient: Each hard capsule contains 117 mg of anhydrous lactose.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Hard capsule

The hard capsules have a white body and cap with two stripes in blue ink on the cap and with “T 140 mg” in blue ink on the body.

4. Clinical Particulars

4.1 Therapeutic Indications

Temomedac hard capsules is indicated for the treatment of:

- adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.

- children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

4.2 Posology And Method Of Administration

Temomedac hard capsules should only be prescribed by physicians experienced in the oncological treatment of brain tumours.

Anti-emetic therapy may be administered (see section 4.4).

Posology

Adult patients with newly-diagnosed glioblastoma multiforme

Temomedac hard capsules is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).

Concomitant phase

TMZ is administered orally at a dose of 75 mg/m² daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions). No dose reductionsare recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non-haematological toxicity criteria. TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:

- absolute neutrophil count (ANC) ⁹/l

- thrombocyte count ⁹/l

- common toxicity criteria (CTC) non-haematological toxicity

During treatment a complete blood count should be obtained weekly. TMZ administration should be temporarily interrupted or permanently discontinued during the concomitant phase according to the haematological and non-haematological toxicity criteria as noted in Table 1.

Table 1. TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Toxicity	TMZ interruption^a	TMZ discontinuation
Absolute Neutrophil Count	⁹/l	< 0.5 x 10⁹/l
Thrombocyte Count	⁹/l	< 10 x 10⁹/l
CTC Non-haematological toxicity (except for alopecia, nausea, vomiting)	CTC Grade 2	CTC Grade 3 or 4

a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ⁹/l; thrombocyte count ⁹/l; CTC non-haematological toxicity

Monotherapy phase

Four weeks after completing the TMZ + RT concomitant phase, TMZ is administered for up to 6 cycles of monotherapy treatment. Dose in Cycle 1 (monotherapy) is 150 mg/m² once daily for 5 days followed by 23 days without treatment. At the start of Cycle 2, the dose is escalated to 200 mg/m² if the CTC nonhaematological toxicity for Cycle 1 is Grade ⁹/l, and the thrombocyte count is ⁹/l. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles. Once escalated, the dose remains at 200 mg/m² per day for the first 5 days of each subsequent cycle except if toxicity occurs.

Dose reductions and discontinuations during the monotherapy phase should be applied according to Tables 2 and 3.

During treatment a complete blood count should be obtained on Day 22 (21 days after the first dose of TMZ). The dose should be reduced or administration discontinued according to Table 3.

Table 2 TMZ dose levels for monotherapy treatment
Dose Level	TMZ Dose (mg/m²/day)	Remarks
–1	100	Reduction for prior toxicity
0	150	Dose during Cycle 1
1	200	Dose during Cycles 2-6 in absence of toxicity

Table 3. TMZ dose reduction or discontinuation during monotherapy treatment
Toxicity	Reduce TMZ by 1 dose level^a	Discontinue TMZ
Absolute Neutrophil Count	< 1.0 x 10⁹/l	See footnote b
Thrombocyte Count	< 50 x 10⁹/l	See footnote b
CTC Non-haematological Toxicity (except for alopecia, nausea, vomiting)	CTC Grade 3	CTC Grade 4^b

a: TMZ dose levels are listed in Table 2.

b: TMZ is to be discontinued if:

• dose level -1 (100 mg/m²) still results in unacceptable toxicity

• the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.

Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma

A treatment cycle comprises 28 days. In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m² once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days). In patients previously treated with chemotherapy, the initial dose is 150 mg/m² once daily, to be increased in the second cycle to 200 mg/m² once daily, for 5 days if there is no haematological toxicity (see section 4.4)

Special populations

Paediatric patients

In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma. There is no clinical experience with use of TMZ in children under the age of 3 years. Experience in older children is very limited (see sections 4.4 and 5.1).

Patients with hepatic or renal impairment

The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment. No data are available on the administration of TMZ in patients with severe hepatic impairment (Child's Class C) or with renal impairment. Based on the pharmacokinetic properties of TMZ, it is unlikely that dose reductions are required in patients with severe hepatic impairment or any degree of renal impairment. However, caution should be exercised when TMZ is administered in these patients.

Elderly patients

Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age. However, elderly patients (> 70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).

Method of administration

Temomedac hard capsules should be administered in the fasting state.

The capsules must be swallowed whole with a glass of water and must not be opened or chewed.

If vomiting occurs after the dose is administered, a second dose should not be administered that day.

4.3 Contraindications

Hypersensitivity to the active substanceor to any of the excipients.

Hypersensitivity to dacarbazine (DTIC).

Severe myelosuppression (see section 4.4).

4.4 Special Warnings And Precautions For Use

Pneumocystis carinii pneumonia

Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42-day schedule were shown to be at particular risk for developing Pneumocystis carinii pneumonia (PCP). Thus, prophylaxis against PCP is required for all patients receiving concomitant TMZ and RT for the 42-day regimen (with a maximum of 49 days) regardless of lymphocyte count. If lymphopenia occurs, they are to continue the prophylaxis until recovery of lymphopenia to grade

There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen. However, all patients receiving TMZ, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.

Malignancies

Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).

Anti-emetic therapy

Nausea and vomiting are very commonly associated with TMZ.

Anti-emetic therapy may be administered prior to or following administration of TMZ.

Adult patients with newly-diagnosed glioblastoma multiforme

Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.

Patients with recurrent or progressive malignant glioma

Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.

Laboratory parameters

Prior to dosing, the following laboratory parameters must be met: ANC ⁹/l and platelet count ⁹/l. A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC> 1.5 x 10⁹/l and platelet count> 100 x10⁹ /l. If ANC falls to < 1.0 x 10⁹/l or the platelet count is < 50 x 10⁹/l during any cycle, the next cycle should be reduced one dose level (see section 4.2). Dose levels include 100 mg/m², 150 mg/m², and 200 mg/m². The lowest recommended dose is 100 mg/m².

Paediatric use

There is no clinical experience with use of TMZ in children under the age of 3 years. Experience in older children and adolescents is very limited (see sections 4.2 and 5.1).

Elderly patients (> 70 years of age)

Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients. Therefore, special care should be taken when TMZ is administered in elderly patients.

Male patients

Men being treated with TMZ should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment (see section 4.6).

Lactose

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Interaction studies have only been performed in adults.

In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).

Administration of TMZ with food resulted in a 33 % decrease in C_max and a 9 % decrease in area under the curve (AUC).

As it cannot be excluded that the change in C_max is clinically significant, Temomedac should be administered without food.

Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ. Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.

No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products. However, since TMZ does not undergo hepatic metabolism and exhibits low protein binding, it is unlikely that it would affect the pharmacokinetics of other medicinal products (seesection 5.2).

Use of TMZ in combination with other myelosuppressive agents may increase the likelihood of myelosuppression.

4.6 Pregnancy And Lactation

Pregnancy

There are no data in pregnant women. In preclinical studies in rats and rabbits receiving 150 mg/m²

TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3). Temomedac hard capsules should not be administered to pregnant women. If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus. Women of childbearing potential should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ.

Lactation

It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.

Male fertility

TMZ can have genotoxic effects. Therefore, men being treated with it should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment, because of the possibility of irreversible infertility due to therapy with TMZ.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. The ability to drive and use machines may be impaired in patients treated with TMZ due to fatigue and somnolence.

4.8 Undesirable Effects

Clinical trial experience

In patients treated with TMZ, whether used in combination with RT or as monotherapy following RT for newly-diagnosed glioblastoma multiforme, or as monotherapy in patients with recurrent or progressive glioma, the reported very common adverse reactions were similar: nausea, vomiting, constipation, anorexia, headache and fatigue. Convulsions were reported very commonly in the newly-diagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma. Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5);the frequency of grade 3-4 laboratory findings is presented after each table.

In the tables undesirable effects are classified according to System Organ Class and frequency.

Frequency groupings are defined according to the following convention: Very common (

Newly-diagnosed glioblastoma multiforme

Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.

Table 4: Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme
System Organ Class	TMZ + concomitant RT n=288*	TMZ monotherapy n=224
Infections and infestations
Common:	Infection, herpes simplex, wound infection, pharyngitis, candidiasis oral	Infection, candidiasis oral
Uncommon:		Herpes simplex, Herpes zoster, influenza–like symptoms
Blood and lymphatic system disorders
Common:	Neutropenia, thrombocytopenia, lymphopenia, leukopenia	Febril neutropenia, thrombocytopenia, anaemia, leukopenia
Uncommon:	Febrile neutropenia, anaemia	Lymphopenia, petechiae
Endocrine disorders
Uncommon:	Cushingoid	Cushingoid
Metabolism and nutrition disorders
Very Common:	Anorexia	Anorexia
Common:	Hyperglycaemia, weight decreased	Weight decreased
Uncommon:	Hypokalemia, alkaline phosphatase increased, weight increased	Hyperglycaemia, weight increased
Psychiatric disorders
Common:	Anxiety, emotional lability, insomnia	Anxiety, depression, emotional lability, insomnia
Uncommon:	Agitation, apathy, behaviour disorder, depression, hallucination	Hallucination, amnesia
Nervous system disorders
Very Common:	Headache	Convulsions, headache
Common:	Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor	Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Uncommon:	Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy	Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Eye disorders
Common:	Vision blurred	Visual field defect, vision blurred, diplopia
Uncommon:	Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain	Visual acuity reduced, eye pain, eyes dry
Ear and labyrinth disorders
Common:	Hearing impairment	Hearing impairment, tinnitus
Uncommon:	Otitis media, tinnitus, hyperacusis, earache	Deafness, vertigo, earache
Cardiac disorders
Uncommon:	Palpitation
Vascular disorders
Common:	Haemorrhage, oedema, oedema leg	Haemorrhage, deep venous thrombosis, oedema leg
Uncommon:	Cerebral haemorrhage, hypertension	Embolism pulmonary, oedema, oedema peripheral
Respiratory, thoracic and mediastinal disorders
Common:	Dyspnoea, coughing	Dyspnoea, coughing
Uncommon:	Pneumonia, upper respiratory infection, nasal congestion	Pneumonia, sinusitis, upper respiratory infection, bronchitis
Gastrointestinal disorders
Very Common:	Constipation, nausea, vomiting	Constipation, nausea, vomiting
Common:	Stomatitis, diarrhoea, abdominal pain, dyspepsia, dysphagia	Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Uncommon:		Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Skin and subcutaneous tissue disorders
Very Common:	Rash, alopecia,	Rash, alopecia
Common:	Dermatitis, dry skin, erythema, pruritus	Dry skin, pruritus
Uncommon:	Skin exfoliation, photosensitivity reaction, pigmentation abnormal	Erythema, pigmentation abnormal, sweating increased
Musculoskeletal and connective tissue disorders
Common:	Muscle weakness, arthralgia	Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Uncommon:	Myopathy, back pain, musculoskeletal pain, myalgia	Myopathy, back pain
Renal and urinary disorders
Common:	Micturition frequency, urinary incontinence	Urinary incontinence
Uncommon:		Dysuria
Reproductive system and breast disorders
Uncommon:	Impotence	Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
General disorders and administration site conditions
Very Common:	Fatigue	Fatigue
Common:	Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion	Allergic reaction, fever, radiation injury, pain, taste perversion
Uncommon:	Asthenia, flushing, hot flushes, condition aggravated, rigors, tongue discolouration, parosmia, thirst	Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder, taste perversion
Investigations
Common:	ALT increased	ALT increased
Uncommon:	Hepatic enzymes increased, Gamma GT increased, AST increased

*A patient who was randomised to the RT arm only, received TMZ + RT.

Laboratory results

Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed. When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophilabnormalities including neutropenic events were observed in 8 % of the patients. Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.

Recurrent or progressive malignant glioma

In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43 %) and vomiting (36 %). These reactions were usually Grade 1 or 2 (0 – 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy. The incidence of severe nausea and vomiting was 4 %.

Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of TMZ.

Table 5. Adverse reactions in patients with recurrent or progressive malignant glioma
Infections and infestations
Rare:	Opportunistic infections, including PCP
Blood and lymphatic system disorders
Very common:	Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
Uncommon:	Pancytopenia, anaemia (grade 3-4), leukopenia
Metabolism and nutrition disorders
Very common:	Anorexia
Common:	Weight decrease
Nervous system disorders
Very common:	Headache
Common:	Somnolence, dizziness, paresthesia
Respiratory, thoracic and mediastinal disorders
Common:	Dyspnoea
Gastrointestinal disorders
Very common:	Vomiting, nausea, constipation
Common:	Diarrhoea, abdominal pain, dyspepsia
Skin and subcutaneous tissue disorders
Common:	Rash, pruritus, alopecia
Very rare:	Erythema multiforme, erythroderma, urticaria, exanthema
General disorders and administration site conditions
Very common:	Fatigue
Common:	Fever, asthenia, rigors, malaise, pain, taste perversion
Very rare:	Allergic reactions, including anaphylaxis, angioedema

Laboratory results

Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma. This led to hospitalisation and/or discontinuation of TMZ in 8 % and 4 %, respectively. Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1-2 weeks. No evidence of cumulative myelosuppression was observed. The presence of thrombocytopenia may increase the risk of bleeding, and the presence of neutropenia or leukopenia may increase the risk of infection.

Gender

In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169 male subjects for whom nadir neutrophil counts were available and 110 female and 174 male subjects for whom nadir platelet counts were available. There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 10⁹/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 10⁹/l ), 9 % vs 3 %, in women vs men in the first cycle of therapy. In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8 % of female vs 4 % of male subjects and Grade 4 thrombocytopenia in 8 % of female vs 3 % of male subjects in the first cycle of therapy. In a study of 288 subjects with newly-diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3 % of female vs 0 % of male subjects and Grade 4 thrombocytopenia in 1 % of female vs 0 % of male subjects in the first cycle of therapy.

Post-marketing experience

Antineoplastic agents, and notably alkylating agents, have been associated with a potential risk of myelodysplastic syndrome (MDS) and secondary malignancies, including leukaemia. Very rare cases of MDS and secondary malignancies, including myeloid leukaemia have been reported in patients treated with regimens that included TMZ. Prolonged pancytopenia, which may result in aplastic anaemia has been reported very rarely.

Cases of toxic epidermal necrolysis and Stevens-Johnson syndrome have been reported very rarely.

Cases of interstitial pneumonitis/pneumonitis have been reported very rarely.

4.9 Overdose

Doses of 500, 750, 1,000, and 1,250 mg/m² (total dose per cycle over 5 days) have been evaluated clinically in patients. Dose-limiting toxicity was haematological and was reported with any dose but is expected to be more severe at higher doses. An overdose of 10,000 mg (total dose in a single cycle, over 5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multiorgan failure and death. There are reports of patients who have taken the recommended dose for more than 5 days of treatment (up to 64 days) with adverse events reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death. In the event of an overdose, haematological evaluation is needed. Supportive measures should be provided as necessary.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other alkylating agents, ATC code: L01A X03

Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC). The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position. Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct.

Newly-diagnosed glioblastoma multiforme

A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286). Patients in the TMZ + RT arm received concomitant TMZ (75 mg/m²) once daily, starting the first day of RT until the last day of RT, for 42 days (with a maximum of 49 days). This was followed by monotherapy TMZ (150 - 200 mg/m²) on Days 1 - 5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT. Patients in the control arm received RT only. Pneumocystis carinii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.

TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57 %) in the RT alone arm, and 62 patients of the 277 (22 %) in the TMZ + RT arm.

The hazard ratio (HR) for overall survival was 1.59 (95 % CI for HR=1.33 -1.91) with a log-rank p < 0.0001 in favour of the TMZ arm. The estimated probability of surviving 2 years or more (26 % vs 10 %) is higher for the RT + TMZ arm. The addition of concomitant TMZ to RT, followed by TMZmonotherapy in the treatment of patients with newly-diagnosed glioblastoma multiforme demonstrated a statistically significant improvement in overall survival (OS) compared with RT alone (Figure 1).

Figure 1 Kaplan-Meier curves for overall

Friday, 9 March 2012

Fluzone Pediatric

Generic Name: influenza virus vaccine (Intradermal route, Intramuscular route)

in-floo-EN-za VYE-rus VAX-een (sub-VEER-ee-on)

Commonly used brand name(s)

In the U.S.

Afluria

Fluarix

Flulaval

Fluvirin

Fluzone

Fluzone High-Dose

Fluzone Pediatric

Available Dosage Forms:

Suspension

Solution

Therapeutic Class: Vaccine

Uses For Fluzone Pediatric

Influenza virus vaccine is used to prevent infection by the influenza viruses. The vaccine works by causing your body to produce its own protection (antibodies) against the disease. It is also known as a “flu shot”.

There are many kinds of influenza viruses, but not all will cause problems in any given year. Therefore, before the influenza vaccine is produced each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses will most likely cause influenza infections for that year. The antigens, which are substances that cause protective antibodies to be formed, for these viruses are included in the influenza vaccine. Usually, the U.S. and Canada use the same influenza vaccine; however, they are not required to do so.

It is necessary to receive an influenza vaccine injection each year, since influenza infections are usually caused by different kinds of viruses and the protection gained by the vaccine lasts less than a year.

Influenza is a virus infection of the throat, bronchial tubes, and lungs. Influenza infection causes fever, chills, cough, headache, muscle aches, and pains in your back, arms, and legs. In addition, adults and children weakened by other diseases or medical conditions, and persons 50 years of age and over, even if they are healthy, may get a much more serious illness that may have to be treated in a hospital. Each year thousands of people die as a result of an influenza infection.

The best way to help prevent influenza infections is to get an influenza vaccination each year, usually in early November. Immunization (getting a vaccine) against influenza is approved for infants 6 months of age and older, all children, and all adults (including 65 years of age and older).

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using Fluzone Pediatric

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Agriflu®, Flulaval™, Fluzone® High-Dose, or Fluzone® Intradermal in the pediatric population. Safety and efficacy have not been established.

Afluria® is not indicated in children younger than 5 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Fluvirin® in children younger than 4 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Fluarix® in children younger than 3 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Fluzone® in children younger than 6 months of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of influenza virus vaccine in the elderly.

Appropriate studies have not been performed on the relationship of age to the effects of Fluzone® Intradermal in the geriatric population. Safety and efficacy have not been established.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of influenza virus vaccine

This section provides information on the proper use of a number of products that contain influenza virus vaccine. It may not be specific to Fluzone Pediatric. Please read with care.

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles or into your skin, usually in the shoulder area.

Sometimes there is not enough flu vaccine for everyone. If this happens and you are a healthy adult, you might need to wait until later in the flu season before getting your vaccination.

You need to get the flu vaccine every year to protect you from the flu.

Some children may need a second dose of the vaccine. If your child needs a second dose of this medicine, it is very important for your child to receive the second dose on schedule. If you must cancel the appointment, make another appointment as soon as possible.

Precautions While Using Fluzone Pediatric

It is very important that your child return to your doctor’s office at the right time if your child needs a second dose of the vaccine. Be sure to notify your doctor of any side effects that occur after you or your child receive this vaccine.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or troubled breathing after you get the injection.

Children who have received a certain brand of the influenza vaccine (Afluria®) have developed a fever and in some cases a fever with seizures. Talk with your doctor if you have concerns about this.

If you are very sick and have a high fever, you will probably need to wait until you are well before your receive this vaccine.

Influenza virus vaccine may not protect everyone who receives the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.

The tip cap of the prefilled syringe for certain brands of the injection (Agriflu®, Fluarix®, Fluvirin®, Fluzone®, Fluzone® High-Dose) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you receive this vaccine.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients receiving Fluzone® Intradermal vaccine.

Make sure your doctor knows if you or your child are using a medicine or treatment that weakens your immune system, such as a steroid, radiation, or cancer treatment. This vaccine may not work as well if you are also using these medicines. Your doctor may still want you to get the vaccine because it can give you some protection.

Fluzone Pediatric Side Effects

In 1976, a number of people who received the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), which is a disease that may cause paralysis. Most of these people were over 25 years of age. Although only 10 out of every one million people who received the vaccine actually developed GBS, this number was 6 times higher than would normally have been expected. Most of the people who got GBS recovered completely.

It is assumed that the “swine flu” virus included in the 1976 vaccine caused the problem, but this has not been proven. Since that time, studies have shown that the risk of acquiring GBS from an influenza vaccine is very low (one out of every million people).

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Cough

diarrhea

fever

headache

irritability

loss of appetite

muscle aches

redness of the eyes

sneezing

sore throat

stuffy or runny nose

vomiting

Less common

Body aches or pain

chills

difficulty with breathing

earache

ear congestion

loss of voice

shivering

swelling or puffiness of the face

tightness in the chest

unusual tiredness or weakness

Rare

Difficulty with swallowing

dizziness

fast heartbeat

hives

itching

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

noisy breathing

puffiness or swelling of the eyelids or around the eyes, lips, or tongue

shortness of breath

skin rash

wheezing

Incidence not known

Agitation

back pain, sudden and severe

back, leg, or stomach pains

black, tarry stools

bleeding gums

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, itching, lumps, numbness, scarring, soreness, stinging, tingling, ulceration, or warmth at the injection site

blindness

blistering, peeling, or loosening of the skin

blood in the urine or stools

blurred vision

bruising, inflammation, rash, redness, swelling, tenderness, or pain at the injection site

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, dry, or itching eyes

change in color vision

change in walking and balance

chest pain

clumsiness or unsteadiness

cold, clammy skin

coma

confusion

dark urine

discharge or excessive tearing

drowsiness

dryness of the throat

eye pain

fainting

fast, weak pulse

feeling hot

feeling of constant movement of self or surroundings

feeling unusually cold

general body swelling

general feeling of discomfort or illness

hallucinations

inability to move the arms and legs

increased sensitivity of the eyes to sunlight

irritation

joint pain, stiffness, or swelling

lack or loss of strength

large, flat, blue, or purplish patches in the skin

lightheadedness

mood or mental changes

muscle weakness, sudden and progressing

nausea

nerve pain

nosebleeds

pain, redness, soreness, swelling, tenderness, or warmth on the skin

painful knees and ankles

paleness of the skin

pinpoint red spots on the skin

redness of the face, neck, arms, and occasionally, upper chest

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

seizures

sensation of spinning

shakiness in the legs, arms, hands, or feet

sores, ulcers, or white spots in the mouth or on the lips

stabbing pain

stiff neck

stomach pain, soreness, or discomfort

sweating

swelling of the face, hands, or feet

swelling of the mouth or throat

swollen, painful, or tender lymph glands in the neck, armpit, or groin

trouble with sleeping

troubled breathing or swallowing

unusual bleeding or bruising

voice changes

weakness of the muscles in your face

yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Sleepiness or unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Fluzone Pediatric side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Fluzone Pediatric resources

Fluzone Pediatric Side Effects (in more detail)
Fluzone Pediatric Use in Pregnancy & Breastfeeding
Fluzone Pediatric Drug Interactions
Fluzone Pediatric Support Group
0 Reviews for Fluzone Pediatric - Add your own review/rating

Compare Fluzone Pediatric with other medications

Influenza Prophylaxis

Sunday, 4 March 2012

Suphedrine

pseudoephedrine hydrochloride

Dosage Form: tablet, film coated, extended release
Rite Aid Corporation Suphedrine Tablets Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 mg

Purpose

Nasal decongestant

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis

temporarily relieves sinus congestion and pressure

Warnings

Do not use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

high blood pressure

heart disease

diabetes

thyroid disease

trouble urinating due to an enlarged prostate gland

When using this product

do not use more than directed

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless

symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over: one tablet every 12 hours not to exceed two tablets in 24 hours

children under 12 years of age: use of product not recommended

Other information

each tablet contains: calcium 45 mg

store at 20° - 25°C (68° - 77°F) in a dry place

protect from light

do not use if blister unit is broken or torn

see carton end panel for lot number and expiration date

this product meets the requirements of USP Drug Release Test 3

Inactive ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient of Sudafed® 12 Hour

Relieves: Nasal & Sinus Congestion due to Colds & Allergies without drowsiness

Suphedrine

Pseudoephedrine Hydrochloride Extended-Release Tablets 120 mg

12 Hour Long-Acting Nasal Decongestant

Maximum Strength

*Capsule-Shaped Tablets

Suphedrine Tablets Carton

Suphedrine
pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	11822-0054
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	L054
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	11822-0054-6	2 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
1		10 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (11822-0054-6)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075153	08/13/2002

Labeler - Rite Aid Corporation (014578892)

Revised: 08/2009Rite Aid Corporation

More Suphedrine resources

Suphedrine Side Effects (in more detail)
Suphedrine Use in Pregnancy & Breastfeeding
Suphedrine Drug Interactions
Suphedrine Support Group
0 Reviews for Suphedrine - Add your own review/rating

Compare Suphedrine with other medications

Nasal Congestion

chlorpheniramine/methscopolamine/pseudoephedrine

Generic Name: chlorpheniramine, methscopolamine, and pseudoephedrine (KLOR fen IR a meen, METH skoe POL a meen, SOO doe ee FED rin)

Brand names: AllePak, Allergy AM-PM Dose Pack, Allergy DN, Amdry-C, Durahist, Hista-Vent PSE, PCM-LA, Pseudo CM TR, Rhinaclear, Time-Hist QD, VisRx Dose Pack, ...show all 20 brand names.

What is chlorpheniramine, methscopolamine, and pseudoephedrine?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Methscopolamine reduces the secretions of certain organs in the body.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine, methscopolamine, and pseudoephedrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine, methscopolamine, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about chlorpheniramine, methscopolamine, and pseudoephedrine?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Do not use this medication if you are allergic to chlorpheniramine or methscopolamine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

Avoid drinking alcohol while you are taking this medication.

What should I discuss with my healthcare provider before taking chlorpheniramine, methscopolamine, and pseudoephedrine?

Do not use a cough or cold if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Dangerous side effects may occur if you take a cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine, methscopolamine, or pseudoephedrine, or if you have:

severe or uncontrolled high blood pressure;

severe coronary artery disease;

narrow angle glaucoma;

a stomach ulcer;

if you are unable to urinate; or

if you are having an asthma attack.

Before using chlorpheniramine, methscopolamine, and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease;

liver disease;

diabetes;

glaucoma;

heart disease, high blood pressure, or circulation problems;

overactive thyroid;

a seizure disorder such as epilepsy;

asthma, emphysema or chronic bronchitis; or

urination problems or an enlarged prostate.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Chlorpheniramine, methscopolamine, and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take chlorpheniramine, methscopolamine, and pseudoephedrine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the instructions on your prescription label. Cold medicine is usually taken for only a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Contact your doctor if your symptoms do not improve or if they get worse while using this medication.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are taking an antihistamine.

Store chlorpheniramine, methscopolamine, and pseudoephedrine at room temperature away from moisture, heat, and light.

See also: Chlorpheniramine/methscopolamine/pseudoephedrine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, severe drowsiness, shallow breathing, ringing in your ears, problems with balance or coordination, hallucinations (seeing things), sleep problems (insomnia), feeling restless or excited, blurred vision, tremors, flushed face, and seizure (convulsions).

What should I avoid while taking chlorpheniramine, methscopolamine, and pseudoephedrine?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated in hot weather. Chlorpheniramine, methscopolamine, and pseudoephedrine increases the risk of heat stroke because it causes decreased sweating and can make you more sensitive to sunlight.

Avoid drinking alcohol. It can increase some of the side effects of chlorpheniramine, methscopolamine, and pseudoephedrine. Narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by chlorpheniramine or methscopolamine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications.

Chlorpheniramine, methscopolamine, and pseudoephedrine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

numbness, tingling, or cold feeling in your hands or feet;

fast, pounding, or uneven heart beats;

painful or difficult urination;

confusion, hallucinations, unusual thoughts or behavior;

feeling short of breath;

tremors or shaking; or

severe drowsiness, feeling light-headed, fainting.

Less serious side effects may include:

dry mouth, stomach pain, changes in appetite;

drowsiness, dizziness, weakness, headache;

dry eyes, blurred vision;

increased sweating;

skin rash; or

feeling nervous or excited (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Chlorpheniramine/methscopolamine/pseudoephedrine Dosing Information

Usual Adult Dose for Allergic Rhinitis:

Chlorpheniramine/methscopolamine/PSE 4 mg-1.25 mg-30 mg/ 5 mL oral syrup:
5 to 10 mL orally every 4 to 6 hours not to exceed 40 mL daily.

Chlorpheniramine/methscopolamine/PSE 4 mg-1.25 mg-60 mg oral tablet, extended release:
1 to 2 tablets orally every 12 hours not to exceed 2 doses daily.

Chlorpheniramine/methscopolamine/PSE 6 mg-2.5 mg-120 mg oral tablet, extended release:
1 tablet orally per day.

Usual Adult Dose for Nasal Congestion:

Usual Adult Dose for Sinus Symptoms:

Usual Pediatric Dose for Allergic Rhinitis:

Chlorpheniramine/methscopolamine/PSE 4 mg-1.25 mg-30 mg/ 5 mL oral syrup:
6 to 11 years: 5 mL orally every 4 to 6 hours not to exceed 20 mL daily.
12 years or older: 5 to 10 mL orally every 4 to 6 hours not to exceed 40 mL daily.

Chlorpheniramine/methscopolamine/PSE 4 mg-1.25 mg-60 mg oral tablet, extended release:
6 to 11 years: 1 tablet orally every 12 hours not to exceed 2 doses daily.
12 years or older: 1 to 2 tablets orally every 12 hours not to exceed 2 doses daily.

Chlorpheniramine/methscopolamine/PSE 6 mg-2.5 mg-120 mg oral tablet, extended release:
12 years or older: 1 tablet orally per day.

Usual Pediatric Dose for Nasal Congestion:

Usual Pediatric Dose for Sinus Symptoms:

What other drugs will affect chlorpheniramine, methscopolamine, and pseudoephedrine?

Many drugs can interact with chlorpheniramine, methscopolamine, and pseudoephedrine. Below is just a partial list. Tell your doctor if you are using any of these drugs:

antacids;

medicine to treat diarrhea (such as Immodium, Kaopectate, Pepto-Bismol);

atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);

glycopyrrolate (Robinul);

mepenzolate (Cantil);

bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine);

a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), timolol (Blocadren), and others;

a barbiturate such as phenobarbital (Luminal, Solfoton); or

an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with chlorpheniramine, methscopolamine, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More chlorpheniramine/methscopolamine/pseudoephedrine resources

Chlorpheniramine/methscopolamine/pseudoephedrine Dosage
Chlorpheniramine/methscopolamine/pseudoephedrine Use in Pregnancy & Breastfeeding
Chlorpheniramine/methscopolamine/pseudoephedrine Drug Interactions
Chlorpheniramine/methscopolamine/pseudoephedrine Support Group
4 Reviews for Chlorpheniramine/methscopolamine/pseudoephedrine - Add your own review/rating

Compare chlorpheniramine/methscopolamine/pseudoephedrine with other medications

Hay Fever
Nasal Congestion
Sinus Symptoms

Where can I get more information?

Your pharmacist can provide more information about chlorpheniramine, methscopolamine, and pseudoephedrine written for health professionals that you may read.

Saturday, 3 March 2012

Surmontil

Generic Name: trimipramine (trye MI pra meen)

Brand Names: Surmontil

What is Surmontil (trimipramine)?

Trimipramine is in a group of drugs called tricyclic antidepressants. Trimipramine affects chemicals in the brain that may become unbalanced.

Trimipramine is used to treat symptoms of depression.

Trimipramine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Surmontil (trimipramine)?

Do not use this medication if you are allergic to trimipramine, or if you have recently had a heart attack. Do not use trimipramine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

What should I discuss with my healthcare provider before taking Surmontil (trimipramine)?

Before taking trimipramine, tell your doctor if you are allergic to any drugs, or if you have:

heart disease;

a history of heart attack, stroke, or seizures;

bipolar disorder (manic-depression);

schizophrenia or other mental illness;

kidney disease;

overactive thyroid;

diabetes (trimipramine may raise or lower blood sugar);

glaucoma; or

problems with urination.

If you have any of these conditions, you may not be able to use trimipramine, or you may need a dosage adjustment or special tests during treatment.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA Pregnancy Category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Trimipramine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from this medication.

Do not give this medication to anyone under 18 years old without the advice of a doctor.

How should I take Surmontil (trimipramine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Follow the directions on your prescription label.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking trimipramine. You may need to stop using the medicine for a short time.

Do not stop using trimipramine without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects. It may take up to 4 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment. Do not use this medication for longer than 3 months unless your doctor has told you to. Store trimipramine at room temperature away from moisture and heat.

See also: Surmontil dosage (in more detail)

What happens if I miss a dose?

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of trimipramine can be fatal.

Symptoms of a trimipramine overdose may include uneven heartbeats, extreme drowsiness, agitation, vomiting, blurred vision, confusion, hallucinations, muscle stiffness, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking Surmontil (trimipramine)?

Avoid drinking alcohol. It can cause dangerous side effects when taken together with trimipramine.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, or other antidepressants). They can add to sleepiness caused by trimipramine.

Grapefruit and grapefruit juice may interact with trimipramine. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.

Trimipramine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Trimipramine can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Surmontil (trimipramine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heart rate;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance;

confusion, hallucinations, or seizure (convulsions);

easy bruising or bleeding, unusual weakness;

feeling light-headed, fainting;

restless muscle movements in your eyes, tongue, jaw, or neck;

urinating more or less than usual;

extreme thirst with headache, nausea, vomiting, and weakness; or

skin rash, bruising, severe tingling, numbness, pain, and muscle weakness.

Less serious side effects may be more likely to occur, such as:

nausea, vomiting, stomach pain, loss of appetite;

constipation or diarrhea;

dry mouth, unpleasant taste;

weakness, lack of coordination;

numbness or tingly feeling;

feeling dizzy, or drowsy;

blurred vision, headache, ringing in your ears;

mild skin rash;

low fever;

breast swelling (in men or women); or

decreased sex drive, impotence, or difficulty having an orgasm.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Surmontil (trimipramine)?

Before taking trimipramine, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Before taking trimipramine, tell your doctor if you are currently using any of the following drugs:

cimetidine (Tagamet);

guanethidine (Ismelin); or

heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).

If you are using any of these drugs, you may not be able to use trimipramine, or you may need dosage adjustments or special tests during treatment.

There are many other medicines that can interact with trimipramine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Surmontil resources

Surmontil Side Effects (in more detail)
Surmontil Dosage
Surmontil Use in Pregnancy & Breastfeeding
Drug Images
Surmontil Drug Interactions
Surmontil Support Group
1 Review for Surmontil - Add your own review/rating

Surmontil Prescribing Information (FDA)

Surmontil Monograph (AHFS DI)

Surmontil Advanced Consumer (Micromedex) - Includes Dosage Information

Surmontil MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Surmontil with other medications

Depression

Where can I get more information?

Your pharmacist has information about trimipramine written for health professionals that you may read.

See also: Surmontil side effects (in more detail)

Thursday, 1 March 2012

Vitrectomy Medications

Drugs associated with Vitrectomy

The following drugs and medications are in some way related to, or used in the treatment of Vitrectomy. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Triesence

Dilzem XL 120, 180 and 240mg hard-capsules

1. Name Of The Medicinal Product

Dilzem XL 120mg Prolonged-release Hard Capsules

Dilzem XL 180mg Prolonged-release Hard Capsules

Dilzem XL 240mg Prolonged-release Hard Capsules

2. Qualitative And Quantitative Composition

Each Dilzem XL 120mg capsule contains diltiazem hydrochloride 120mg.

Each Dilzem XL 180mg capsule contains diltiazem hydrochloride 180mg.

Each Dilzem XL 240mg capsule contains diltiazem hydrochloride 240mg.

Excipients: Sucrose 25.2mg in each XL 120mg capsule.

Sucrose 37.8mg in each XL 180mg capsule.

Sucrose 50.4mg in each XL 240mg capsule.

For full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Prolonged-release capsule, hard.

White, hard gelatin capsules, printed with e120 and containing roughly spherical white to off-white beads.

White, hard gelatin capsules, printed with e180 and containing roughly spherical white to off-white beads.

White, hard gelatin capsules, printed with e240 and containing roughly spherical white to off-white beads.

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis and treatment of angina pectoris.

Treatment of mild to moderate hypertension.

4.2 Posology And Method Of Administration

Oral use only.

Adults:

Hypertension: The usual initial dose is one 180mg capsule per day (corresponding to 180mg of diltiazem hydrochloride once daily). Depending upon the clinical response the dosage may be increased stepwise to 360mg/day if required.

Angina Pectoris: The usual initial dose is one 180mg capsule per day (corresponding to 180mg of diltiazem hydrochloride once daily). Depending upon the clinical response the dosage may be increased stepwise to 360mg/day if required.

Elderly patients and those with renal or hepatic impairment:

Dosage should commence at the lower level of 120mg once daily and be increased slowly. Do not increase the dose if the heart rate falls below 50 beats per minute.

Children:

This product is not recommended for use in children.

4.3 Contraindications

- Use in women of child-bearing potential

- Concomitant administration of dantrolene infusion due to the risk of ventricular fibrillation

- Shock

- Acute cardiac infarct with complications (bradycardia, severe hypotension, left heart insufficiency)

- Bradycardia (pulse rate, at rest, of less than 50 bpm), hypotension (less than 90 mm Hg systole), second or third degree heart block or sick sinus syndrome, except in the presence of a functioning ventricular pacemaker

- Atrial fibrillation/flutter and simultaneous presence of a WPW (Wolff-Parkinson-White) syndrome (increased risk of triggering a ventricular tachycardia)

- Manifest myocardial insufficiency

- Left ventricular failure with stasis

- Hypersensitivity to diltiazem or any of the excipients

4.4 Special Warnings And Precautions For Use

- Capsules should not be sucked or chewed.

- The use of diltiazem hydrochloride in diabetic patients may require adjustment of their control.

- Prior to general anaesthesia, the anaesthetist must be informed of ongoing diltiazem treatment (see section 4.5).

- Increase of plasma concentrations of diltiazem may be observed in the elderly and in patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment.

The product should be used with caution in patients with hepatic dysfunction. Abnormalities of liver function may occur during therapy. Very occasional reports of abnormal liver function have been received, these reactions have been reversible upon discontinuation of therapy.

- First degree AV block or prolonged PR interval. Diltiazem prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second or third degree AV block (see section 4.5 for information concerning beta-blockers and digitalis).

- Close observation is necessary in patients with reduced left ventricular function and bradycardia (risk of exacerbation) (see section 4.3).

- Diltiazem is not recommended for use in patients with acute porphyria unless other safer alternatives are not available.

- There have been reports of calcium-channel blockers exacerbating muscle weakness in patients with myasthenia gravis. Diltiazem should be used with caution in such patients.

- Like other calcium channel antagonists, diltiazem has an inhibitory effect on intestinal motility. Therefore it should be used with caution in patients at risk to develop an intestinal obstruction. Residues from slow release formulations of the product may pass into the patient's stools; however, this finding has no clinical relevance.

- Calcium channel blocking agents, such as diltiazem, may be associated with mood changes, including depression.

- Owing to the presence of sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

As with any drug given over prolonged periods, laboratory parameters should be monitored at regular intervals.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use contraindicated:

Dantrolene (infusion): Lethal ventricular fibrillation is regularly observed in animals when intravenous verapamil and dantrolene are administered concomitantly. The combination of a calcium antagonist and dantrolene is therefore potentially dangerous (see section 4.3).

Concomitant use requiring caution:

Anaesthetics: Anaesthetists should be warned that a patient is taking diltiazem. The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anaesthetics may be potentiated by calcium channel blockers. When used concomitantly, anaesthetics and calcium channel blockers should be titrated carefully.

Statins: Due to metabolic interaction via CYP3A4, treatment with HMG CoA reductase inhibitors such as simvastatin, atorvastatin or lovastatin, in combination with diltiazem, should be started at the lowest possible dose and titrated upwards. If a patient is already taking an HMG CoA reductase inhibitor a reduction in that dose should be considered and re-titration against serum cholesterol concentrations carried out. Patient monitoring for signs and symptoms of rhabdomyolysis and myopathy is recommended. CYP3A4 is not involved in the metabolism of fluvastatin, pravastatin and rosuvastatin.

Lithium: Risk of increase in lithium-induced neurotoxicity.

Warfarin: There have been reports in the literature of diltiazem interactions with warfarin.

Nitrate derivatives: Increased hypotensive effects and faintness (additive vasodilatating effects): In all the patients treated with calcium antagonists, the prescription of nitrate derivatives should only be carried out at gradually increasing doses.

Theophylline: Increase in circulating theophylline levels. It is recommended that the plasma theophylline concentrations be assayed and that the dose should be adjusted if necessary.

Alpha-antagonists: Increased antihypertensive effects:

Concomitant treatment with alpha-antagonists may produce or aggravate hypotension. The combination of diltiazem with an alpha-antagonist should be considered only with the strict monitoring of the blood pressure.

Amiodarone, digoxin: Increased risk of bradycardia:

Caution is required when these are combined with diltiazem, particularly in elderly subjects and when high doses are used.

Amiodarone in combination with diltiazem may also cause AV block and myocardial depression.

It is recommended that the plasma digoxin concentrations be assayed and that the dose should be adjusted if necessary. Cardiac glycosides may cause a greater degree of AV blocking, reduce the heart rate or induce a hypotensive effect.

Beta-blockers: Possibility of rhythm disturbances (pronounced bradycardia, sinus arrest), sino-atrial and atrio-ventricular conduction disturbances and heart failure (synergistic effect). Such a combination must only be used under close clinical and ECG monitoring, particularly at the beginning of treatment.

Other antiarrhythmic agents:

Since diltiazem has antiarrhythmic properties, its concomitant prescription with other antiarrhythmic agents is not recommended (additive risk of increased cardiac adverse effects). This combination should only be used under close clinical and ECG monitoring.

Diuretics, ACE inhibitors or other antihypertensive agents:

Patients should be carefully monitored when taking diltiazem concomitantly with these agents.

Carbamazepine: Increase in circulating carbamazepine levels:

It is recommended that the plasma carbamazepine concentrations be assayed and that the dose should be adjusted if necessary.

Rifampicin: Risk of decrease of diltiazem plasma levels after initiating therapy with rifampicin: The patient should be carefully monitored when initiating or discontinuing rifampicin treatment.

Anti-H2 agents (cimetidine, ranitidine): Increase in plasma diltiazem concentrations. Patients currently receiving diltiazem therapy should be carefully monitored when initiating or discontinuing therapy with anti-H2 agents. An adjustment in diltiazem daily dose may be necessary.

Ciclosporin: Increase in circulating cyclosporin levels:

It is recommended that the cyclosporin dose be reduced, renal function be monitored, circulating cyclosporin levels be assayed and that the dose should be adjusted during combined therapy and after its discontinuation.

Benzodiazepines (midazolam, triazolam): Diltiazem significantly increases plasma concentrations of midazolam and triazolam and prolongs their half-life. Special care should be taken when prescribing short-acting benzodiazepines metabolized by the CYP3A4 pathway in patients using diltiazem.

Corticosteroids (methylprednisolone): Inhibition of methylprednisolone metabolism (CYP3A4) and inhibition of P-glycoprotein: The patient should be monitored when initiating methylprednisolone treatment. An adjustment in the dose of methylprednisolone may be necessary.

General information to be taken into account:

Due to the potential for additive effects, caution and careful titration are necessary in patients receiving diltiazem concomitantly with other agents known to affect cardiac contractility and/or conduction.

Diltiazem is metabolized by CYP3A4. A moderate (less than 2 fold) increase of diltiazem plasma concentration in cases of co administration with a stronger CYP3A4 inhibitor has been documented. Diltiazem is also a CYP3A4 isoform inhibitor. Co administration with other CYP3A4 substrates may result in an increase in plasma concentration of either co administered drug. Co administration of diltiazem with a CYP3A4 inducer may result in a decrease of diltiazem plasma concentrations.

Simultaneous administration with enzyme inducers such as rifampicin and phenobarbital may lead to reduced activity of diltiazem.

Antihypertensives: Diltiazem hydrochloride should only be administered with great care to patients receiving concurrent treatment with antihypertensives or other hypotensive agents including halogenated anaesthetics or drugs with moderate protein binding.

Diltiazem hydrochloride will not protect against effects of withdrawal of ß-adrenoceptor blocking agents, nor the rebound effects seen with various antihypertensives.

There may be an additive effect when diltiazem is used with drugs which may induce bradycardia or with other antihypertensives.

4.6 Pregnancy And Lactation

There is very limited data from the use of diltiazem in pregnant patients. Diltiazem has been shown to have reproductive toxicity in certain animal species (rat, mice, rabbit). Diltiazem should not be used during pregnancy, as well as in women of child bearing potential not using effective contraception (see section 4.3).

Diltiazem is excreted in breast milk at low concentrations. Breast feeding while taking this drug should be avoided. If use of diltiazem is considered medically essential, an alternative method of infant feeding should be instituted.

4.7 Effects On Ability To Drive And Use Machines

On the basis of reported adverse drug reactions, i.e. dizziness (common), malaise (common), the ability to drive and use machines could be altered. However, no studies have been performed.

4.8 Undesirable Effects

The following CIOMS frequency rating is used, when applicable: Very common (

Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

	Very common	Common	Uncommon	Rare	Not known
Blood and lymphatic system disorders					Thrombocytopenia, lymphadenopathy, eosinophilia
Psychiatric disorders			Nervousness, insomnia		Hallucinations, mood changes (including depression), personality change
Nervous system disorders		Headache, dizziness			Extrapyramidal syndrome, gait abnormality, syncope, amnesia, paraesthesia, somnolence, tremor
Cardiac disorders		Atrioventricular block (may be of first, second or third degree; bundle branch block may occur), palpitations	Bradycardia		Sinoatrial block, congestive heart failure, arrhythmia, angina
Vascular disorders		Flushing	Orthostatic hypotension		Vasculitis (including leukocytoclastic vasculitis), hypotension
Gastrointestinal disorders		Constipation, dyspepsia, gastric pain, nausea	Vomiting, diarrhea	Dry mouth	Gingival hyperplasia, gingivitis
Hepatobiliary disorders					Hepatitis
Skin and subcutaneous tissue disorders		Erythema		Urticaria	Allergic skin reactions, photosensitivity (including lichenoid keratosis at sun exposed skin areas), angioneurotic oedema, rash, erythema multiforme (including Steven-Johnson's syndrome and toxic epidermal necrolysis), sweating, exfoliative dermatitis, acute generalized exanthematous pustulosis, occasionally desquamative erythema with or without fever, petechiae, pruritus
Reproductive system and breast disorders					Gynecomastia, sexual difficulties
General disorders and administration site conditions	Peripheral oedema	Oedema, asthenia, malaise
Eye disorders					Amblyopia, eye irritation
Investigations			Hepatic enzymes increase (AST, ALT, LDH, ALP increase)		CK elevation, weight increase
Respiratory, thoracic and mediastinal disorders					Dyspnoea, epistaxis, nasal congestion
Metabolism and nutrition disorders					Anorexia, hyperglycaemia
Renal and urinary disorders					Nocturia, polyuria
Musculoskeletal and connective tissue disorders					Osteoarticular pain, muscle pain, muscle weakness
Ear and labyrinth disorders					Tinnitus

4.9 Overdose

The clinical effects of acute overdose can involve pronounced hypotension possibly leading to collapse, sinus bradycardia with or without isorhythmic dissociation, and atrioventricular conduction disturbances.

Experience of overdosage in man is limited but cases of spontaneous recovery have been reported. However, it is recommended that patients with suspected overdose should be placed under observation in a coronary care unit with facilities available for treatment of any possible hypotension and conduction disturbances that may occur. Most patients suffering from overdosage of diltiazem become hypotensive within 8 hours of ingestion. With bradycardia and first to third degree atrioventricular block also developing cardiac arrest may ensue. Hyperglycaemia is also a recognised complication. The elimination half-life of diltiazem after overdosage is estimated to be about 5.5 - 10.2 hours. If a patient presents early after overdose, gastric lavage should be performed and activated charcoal administered to reduce diltiazem absorption.

Hypotension should be corrected with plasma expanders, intravenous calcium gluconate and inotropic agents (dopamine, dobutamine or isoprenaline). Symptomatic bradycardia and high grade AV block may respond to atropine, isoprenaline or occasionally cardiac pacing which may be useful if cardiac standstill occurs.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Diltiazem has pharmacologic actions similar to those of other calcium channel blocking agents such as nifedipine or verapamil. The principal physiologic action of diltiazem is to inhibit the transmembrane influx of extracellular calcium ions across the membranes of myocardial cells and vascular smooth muscle cells.

Calcium plays important roles in the excitation-contraction coupling processes of the heart and vascular smooth muscle cells and in the electrical discharge of the specialised conduction cells of the heart. The membranes of these cells contain numerous channels that carry a slow inward current and that are selective for calcium.

By inhibiting calcium influx, diltiazem inhibits the contractile processes of cardiac and vascular smooth muscle, thereby dilating the main coronary and systemic arteries. Dilation of systemic arteries by diltiazem results in a decrease in total peripheral resistance, a decrease in systemic blood pressure and a decrease in the afterload of the heart. The reduction in afterload, seen at rest and with exercise, and its resultant decrease in myocardial oxygen consumption are thought to be responsible for the beneficial effects of diltiazem in patients with chronic stable angina pectoris. In patients with prinzmetal variant angina, inhibition of spontaneous and ergonovine-induced coronary artery spasm by diltiazem results in increased myocardial oxygen delivery.

5.2 Pharmacokinetic Properties

a) General Characteristics

Absorption: Capsules seem to have a similar bioavailability to tablets (30-40%), with peak concentrations for the prolonged release product after 8-11 hours compared with 1-2 hours after the conventional release product. The relatively low bioavailability is due to first pass metabolism in the liver to an active metabolite.

Distribution: Diltiazem hydrochloride is lipophilic and has a high volume of distribution. Typical study results are in the range of 3-8 litres/kg. Protein binding is about 80% and is not concentration-dependent at levels likely to be found clinically. Protein binding does not appear to be influenced by phenylbutazone, warfarin, propranolol, salicylic acid or digoxin.

Metabolism: Diltiazem hydrochloride is extensively metabolised in the liver. N-monodesmethyl diltiazem is the predominant metabolite followed quantitatively by the desacetyl metabolite, which has some pharmacological activity. The efficacy of the metabolites, desacetyl diltiazem and N-monodesmethyl diltiazem is 25-50% and about 20% respectively of that of diltiazem. In liver function disorders delayed metabolism in the liver is likely. These metabolites are converted to conjugates, generally the glucuronide or the sulphate.

Elimination: Diltiazem is excreted in the form of its metabolites (about 35%) and in the non-metabolised form (about 2-4%) via the kidneys while about 60% is excreted via the faeces. The average elimination half life period for diltiazem is 6-8 hours but may vary between 2 and 11 hours. Although the elimination half life is not changed after repeated oral administration, diltiazem and also the desacetyl metabolite show a slight accumulation in the plasma.

b) Characteristics in Patients

Decreased first-pass metabolism in the elderly tends to result in increased plasma concentrations of calcium antagonists but no major changes have been found with diltiazem. Renal impairment did not cause significant changes in diltiazem pharmacokinetics. Plasma concentrations of diltiazem also tend to be higher in hepatic cirrhosis due to impaired oxidative metabolism.

5.3 Preclinical Safety Data

Chronic toxicity studies in rats revealed no remarkable changes at oral doses up to 125 mg/kg/day although there was a 60% mortality at this dose. In dogs chronically treated with oral doses of 20 mg/kg/day, transient rises in SGPT were observed. Embryotoxicity has been reported in mice, rats and rabbits following i.p. administration of diltiazem. Main types of malformations included limb and tail defects with a small number of vertebral and rib deformities also noted.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Fumaric acid

Talc

Povidone

Sugar spheres (containing sucrose and maize starch)

Ammonio methacrylate copolymer Type B

Ammonio methacrylate copolymer Type A

The capsule shell contains:

Gelatin

Titanium dioxide (E171)

The printing ink contains:

Shellac

Black iron oxide (E172)

Propylene glycol (E1520)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Two years from the date of manufacture.

6.4 Special Precautions For Storage

Do not store above 25^oC. Store in the original package in order to protect from light and moisture.

6.5 Nature And Contents Of Container

Jaysquare container, containing 7, 20, 30, 50, 60 or 100 capsules.

PVC/PVDC blister pack, containing 4, 28 or 30 capsules.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Cephalon Limited

1 Albany Place

Hyde Way

Welwyn Garden City

Hertfordshire

AL7 3BT

8. Marketing Authorisation Number(S)

Dilzem XL 120 mg – PL 21799/0003

Dilzem XL 180 mg – PL 21799/0004

Dilzem XL 240 mg – PL 21799/0005

9. Date Of First Authorisation/Renewal Of The Authorisation

30 January 2006

10. Date Of Revision Of The Text

November 2010

11. LEGAL CATEGORY

POM

Tuesday, 13 March 2012

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Friday, 9 March 2012

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