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Drugs for subcutaneous and mycoses

Itraconazole is an orally active triazole antifungal agent, having broad-spectrum activity and a favourable pharmacokinetic profile. Itraconazole inhibits cytochrome p-450 dependent enzymes resulting in impairment of the biosynthesis of ergoesterol, a major component of the cell membrane of yeast and fungal cells.

Tinea corporis, Tinea cruris: 100 mg daily for 2 weeks.

Tinea pedis, Tinea manus: 100 mg daily for 4 weeks.

Vulvovaginal candidiasis: 200 mg twice daily for 1 day or 200 mg daily for 3 days.

Fungal keratitis: 200 mg daily for 3 weeks.

Pityriasis versicolor: 200 mg daily for 1 week.

Oropharyngeal candidiasis: 100 mg daily (200 mg for AIDS patients) for 15 days.

Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for 7 days (course), subsequent courses repeated after 21 day interval; fingernails 2 courses and toenails 3 courses.

Histoplasmosis: 200 mg 1-2 times daily.

Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective) 200 mg once daily, increased in invasive or in cryptococcal meningitis to 200 mg twice daily.

Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients: 100mg daily. Or as directed by the physician.

Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, hepatitis, cholestatic jaundice, peripheral neuropathy have been reported.

The drug is contraindicated in patients with a known history of hypersensitivity to it. The drug is also contraindicated in pregnant women and patients with known severe hepatic disease. It is also contraindicated with Rifampicin therapy.

Hepatic enzyme value should be monitored in patients with preexisting hepatic function abnormalities. It should also be done periodically in all patients receiving continuous treatment for more than one month or at any time a patients develops sign and symptoms suggestive liver dysfunction.

Itraconazole inhibits the metabolism of Cyclosporine and Warfarin. Interaction with Terfenadine, Phenobarbitone, Midazolam has been reported.

Not recommended during pregnancy & lactation, unless otherwise indicated by the physician.

The efficacy and safety of the Itraconazole capsule have not been established in pediatric patients.

There is no experience of overdosage with itraconazole.

Store below 30°C, away from light & in a dry place. Keep out of the reach of children.

Drugs for subcutaneous and mycoses

Itraconazole is an orally active triazole antifungal agent, having broad-spectrum activity and a favourable pharmacokinetic profile. Itraconazole inhibits cytochrome p-450 dependent enzymes resulting in impairment of the biosynthesis of ergoesterol, a major component of the cell membrane of yeast and fungal cells.

Tinea corporis, Tinea cruris: 100 mg daily for 2 weeks.

Tinea pedis, Tinea manus: 100 mg daily for 4 weeks.

Vulvovaginal candidiasis: 200 mg twice daily for 1 day or 200 mg daily for 3 days.

Fungal keratitis: 200 mg daily for 3 weeks.

Pityriasis versicolor: 200 mg daily for 1 week.

Oropharyngeal candidiasis: 100 mg daily (200 mg for AIDS patients) for 15 days.

Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for 7 days (course), subsequent courses repeated after 21 day interval; fingernails 2 courses and toenails 3 courses.

Histoplasmosis: 200 mg 1-2 times daily.

Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective) 200 mg once daily, increased in invasive or in cryptococcal meningitis to 200 mg twice daily.

Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients: 100mg daily. Or as directed by the physician.

Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, hepatitis, cholestatic jaundice, peripheral neuropathy have been reported.

The drug is contraindicated in patients with a known history of hypersensitivity to it. The drug is also contraindicated in pregnant women and patients with known severe hepatic disease. It is also contraindicated with Rifampicin therapy.

Hepatic enzyme value should be monitored in patients with preexisting hepatic function abnormalities. It should also be done periodically in all patients receiving continuous treatment for more than one month or at any time a patients develops sign and symptoms suggestive liver dysfunction.

Itraconazole inhibits the metabolism of Cyclosporine and Warfarin. Interaction with Terfenadine, Phenobarbitone, Midazolam has been reported.

Not recommended during pregnancy & lactation, unless otherwise indicated by the physician.

The efficacy and safety of the Itraconazole capsule have not been established in pediatric patients.

There is no experience of overdosage with itraconazole.

Store below 30°C, away from light & in a dry place. Keep out of the reach of children.

Drugs for subcutaneous and mycoses

Itraconazole is an orally active triazole antifungal agent, having broad-spectrum activity and a favourable pharmacokinetic profile. Itraconazole inhibits cytochrome p-450 dependent enzymes resulting in impairment of the biosynthesis of ergoesterol, a major component of the cell membrane of yeast and fungal cells.

Tinea corporis, Tinea cruris: 100 mg daily for 2 weeks.

Tinea pedis, Tinea manus: 100 mg daily for 4 weeks.

Vulvovaginal candidiasis: 200 mg twice daily for 1 day or 200 mg daily for 3 days.

Fungal keratitis: 200 mg daily for 3 weeks.

Pityriasis versicolor: 200 mg daily for 1 week.

Oropharyngeal candidiasis: 100 mg daily (200 mg for AIDS patients) for 15 days.

Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for 7 days (course), subsequent courses repeated after 21 day interval; fingernails 2 courses and toenails 3 courses.

Histoplasmosis: 200 mg 1-2 times daily.

Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective) 200 mg once daily, increased in invasive or in cryptococcal meningitis to 200 mg twice daily.

Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients: 100mg daily. Or as directed by the physician.

Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, hepatitis, cholestatic jaundice, peripheral neuropathy have been reported.

The drug is contraindicated in patients with a known history of hypersensitivity to it. The drug is also contraindicated in pregnant women and patients with known severe hepatic disease. It is also contraindicated with Rifampicin therapy.

Hepatic enzyme value should be monitored in patients with preexisting hepatic function abnormalities. It should also be done periodically in all patients receiving continuous treatment for more than one month or at any time a patients develops sign and symptoms suggestive liver dysfunction.

Itraconazole inhibits the metabolism of Cyclosporine and Warfarin. Interaction with Terfenadine, Phenobarbitone, Midazolam has been reported.

Not recommended during pregnancy & lactation, unless otherwise indicated by the physician.

The efficacy and safety of the Itraconazole capsule have not been established in pediatric patients.

There is no experience of overdosage with itraconazole.

Store below 30°C, away from light & in a dry place. Keep out of the reach of children.

Drugs for subcutaneous and mycoses

Itraconazole is an orally active triazole antifungal agent, having broad-spectrum activity and a favourable pharmacokinetic profile. Itraconazole inhibits cytochrome p-450 dependent enzymes resulting in impairment of the biosynthesis of ergoesterol, a major component of the cell membrane of yeast and fungal cells.

Tinea corporis, Tinea cruris: 100 mg daily for 2 weeks.

Tinea pedis, Tinea manus: 100 mg daily for 4 weeks.

Vulvovaginal candidiasis: 200 mg twice daily for 1 day or 200 mg daily for 3 days.

Fungal keratitis: 200 mg daily for 3 weeks.

Pityriasis versicolor: 200 mg daily for 1 week.

Oropharyngeal candidiasis: 100 mg daily (200 mg for AIDS patients) for 15 days.

Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for 7 days (course), subsequent courses repeated after 21 day interval; fingernails 2 courses and toenails 3 courses.

Histoplasmosis: 200 mg 1-2 times daily.

Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective) 200 mg once daily, increased in invasive or in cryptococcal meningitis to 200 mg twice daily.

Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients: 100mg daily. Or as directed by the physician.

Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, hepatitis, cholestatic jaundice, peripheral neuropathy have been reported.

The drug is contraindicated in patients with a known history of hypersensitivity to it. The drug is also contraindicated in pregnant women and patients with known severe hepatic disease. It is also contraindicated with Rifampicin therapy.

Hepatic enzyme value should be monitored in patients with preexisting hepatic function abnormalities. It should also be done periodically in all patients receiving continuous treatment for more than one month or at any time a patients develops sign and symptoms suggestive liver dysfunction.

Itraconazole inhibits the metabolism of Cyclosporine and Warfarin. Interaction with Terfenadine, Phenobarbitone, Midazolam has been reported.

Not recommended during pregnancy & lactation, unless otherwise indicated by the physician.

The efficacy and safety of the Itraconazole capsule have not been established in pediatric patients.

There is no experience of overdosage with itraconazole.

Store below 30°C, away from light & in a dry place. Keep out of the reach of children.

Drugs for subcutaneous and mycoses

Itraconazole is an orally active triazole antifungal agent, having broad-spectrum activity and a favourable pharmacokinetic profile. Itraconazole inhibits cytochrome p-450 dependent enzymes resulting in impairment of the biosynthesis of ergoesterol, a major component of the cell membrane of yeast and fungal cells.

Tinea corporis, Tinea cruris: 100 mg daily for 2 weeks.

Tinea pedis, Tinea manus: 100 mg daily for 4 weeks.

Vulvovaginal candidiasis: 200 mg twice daily for 1 day or 200 mg daily for 3 days.

Fungal keratitis: 200 mg daily for 3 weeks.

Pityriasis versicolor: 200 mg daily for 1 week.

Oropharyngeal candidiasis: 100 mg daily (200 mg for AIDS patients) for 15 days.

Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for 7 days (course), subsequent courses repeated after 21 day interval; fingernails 2 courses and toenails 3 courses.

Histoplasmosis: 200 mg 1-2 times daily.

Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective) 200 mg once daily, increased in invasive or in cryptococcal meningitis to 200 mg twice daily.

Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients: 100mg daily. Or as directed by the physician.

Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, hepatitis, cholestatic jaundice, peripheral neuropathy have been reported.

The drug is contraindicated in patients with a known history of hypersensitivity to it. The drug is also contraindicated in pregnant women and patients with known severe hepatic disease. It is also contraindicated with Rifampicin therapy.

Hepatic enzyme value should be monitored in patients with preexisting hepatic function abnormalities. It should also be done periodically in all patients receiving continuous treatment for more than one month or at any time a patients develops sign and symptoms suggestive liver dysfunction.

Itraconazole inhibits the metabolism of Cyclosporine and Warfarin. Interaction with Terfenadine, Phenobarbitone, Midazolam has been reported.

Not recommended during pregnancy & lactation, unless otherwise indicated by the physician.

The efficacy and safety of the Itraconazole capsule have not been established in pediatric patients.

There is no experience of overdosage with itraconazole.

Store below 30°C, away from light & in a dry place. Keep out of the reach of children.

Drugs for subcutaneous and mycoses

Itraconazole is an orally active triazole antifungal agent, having broad-spectrum activity and a favourable pharmacokinetic profile. Itraconazole inhibits cytochrome p-450 dependent enzymes resulting in impairment of the biosynthesis of ergoesterol, a major component of the cell membrane of yeast and fungal cells.

Tinea corporis, Tinea cruris: 100 mg daily for 2 weeks.

Tinea pedis, Tinea manus: 100 mg daily for 4 weeks.

Vulvovaginal candidiasis: 200 mg twice daily for 1 day or 200 mg daily for 3 days.

Fungal keratitis: 200 mg daily for 3 weeks.

Pityriasis versicolor: 200 mg daily for 1 week.

Oropharyngeal candidiasis: 100 mg daily (200 mg for AIDS patients) for 15 days.

Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for 7 days (course), subsequent courses repeated after 21 day interval; fingernails 2 courses and toenails 3 courses.

Histoplasmosis: 200 mg 1-2 times daily.

Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective) 200 mg once daily, increased in invasive or in cryptococcal meningitis to 200 mg twice daily.

Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients: 100mg daily. Or as directed by the physician.

Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, hepatitis, cholestatic jaundice, peripheral neuropathy have been reported.

The drug is contraindicated in patients with a known history of hypersensitivity to it. The drug is also contraindicated in pregnant women and patients with known severe hepatic disease. It is also contraindicated with Rifampicin therapy.

Hepatic enzyme value should be monitored in patients with preexisting hepatic function abnormalities. It should also be done periodically in all patients receiving continuous treatment for more than one month or at any time a patients develops sign and symptoms suggestive liver dysfunction.

Itraconazole inhibits the metabolism of Cyclosporine and Warfarin. Interaction with Terfenadine, Phenobarbitone, Midazolam has been reported.

Not recommended during pregnancy & lactation, unless otherwise indicated by the physician.

The efficacy and safety of the Itraconazole capsule have not been established in pediatric patients.

There is no experience of overdosage with itraconazole.

Store below 30°C, away from light & in a dry place. Keep out of the reach of children.

Drugs for subcutaneous and mycoses

Itraconazole is an orally active triazole antifungal agent, having broad-spectrum activity and a favourable pharmacokinetic profile. Itraconazole inhibits cytochrome p-450 dependent enzymes resulting in impairment of the biosynthesis of ergoesterol, a major component of the cell membrane of yeast and fungal cells.

Tinea corporis, Tinea cruris: 100 mg daily for 2 weeks.

Tinea pedis, Tinea manus: 100 mg daily for 4 weeks.

Vulvovaginal candidiasis: 200 mg twice daily for 1 day or 200 mg daily for 3 days.

Fungal keratitis: 200 mg daily for 3 weeks.

Pityriasis versicolor: 200 mg daily for 1 week.

Oropharyngeal candidiasis: 100 mg daily (200 mg for AIDS patients) for 15 days.

Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for 7 days (course), subsequent courses repeated after 21 day interval; fingernails 2 courses and toenails 3 courses.

Histoplasmosis: 200 mg 1-2 times daily.

Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective) 200 mg once daily, increased in invasive or in cryptococcal meningitis to 200 mg twice daily.

Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients: 100mg daily. Or as directed by the physician.

Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, hepatitis, cholestatic jaundice, peripheral neuropathy have been reported.

The drug is contraindicated in patients with a known history of hypersensitivity to it. The drug is also contraindicated in pregnant women and patients with known severe hepatic disease. It is also contraindicated with Rifampicin therapy.

Hepatic enzyme value should be monitored in patients with preexisting hepatic function abnormalities. It should also be done periodically in all patients receiving continuous treatment for more than one month or at any time a patients develops sign and symptoms suggestive liver dysfunction.

Itraconazole inhibits the metabolism of Cyclosporine and Warfarin. Interaction with Terfenadine, Phenobarbitone, Midazolam has been reported.

Not recommended during pregnancy & lactation, unless otherwise indicated by the physician.

The efficacy and safety of the Itraconazole capsule have not been established in pediatric patients.

There is no experience of overdosage with itraconazole.

Store below 30°C, away from light & in a dry place. Keep out of the reach of children.

Drugs for subcutaneous and mycoses

Itraconazole is an orally active triazole antifungal agent, having broad-spectrum activity and a favourable pharmacokinetic profile. Itraconazole inhibits cytochrome p-450 dependent enzymes resulting in impairment of the biosynthesis of ergoesterol, a major component of the cell membrane of yeast and fungal cells.

Tinea corporis, Tinea cruris: 100 mg daily for 2 weeks.

Tinea pedis, Tinea manus: 100 mg daily for 4 weeks.

Vulvovaginal candidiasis: 200 mg twice daily for 1 day or 200 mg daily for 3 days.

Fungal keratitis: 200 mg daily for 3 weeks.

Pityriasis versicolor: 200 mg daily for 1 week.

Oropharyngeal candidiasis: 100 mg daily (200 mg for AIDS patients) for 15 days.

Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for 7 days (course), subsequent courses repeated after 21 day interval; fingernails 2 courses and toenails 3 courses.

Histoplasmosis: 200 mg 1-2 times daily.

Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective) 200 mg once daily, increased in invasive or in cryptococcal meningitis to 200 mg twice daily.

Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients: 100mg daily. Or as directed by the physician.

Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, hepatitis, cholestatic jaundice, peripheral neuropathy have been reported.

The drug is contraindicated in patients with a known history of hypersensitivity to it. The drug is also contraindicated in pregnant women and patients with known severe hepatic disease. It is also contraindicated with Rifampicin therapy.

Hepatic enzyme value should be monitored in patients with preexisting hepatic function abnormalities. It should also be done periodically in all patients receiving continuous treatment for more than one month or at any time a patients develops sign and symptoms suggestive liver dysfunction.

Itraconazole inhibits the metabolism of Cyclosporine and Warfarin. Interaction with Terfenadine, Phenobarbitone, Midazolam has been reported.

Not recommended during pregnancy & lactation, unless otherwise indicated by the physician.

The efficacy and safety of the Itraconazole capsule have not been established in pediatric patients.

There is no experience of overdosage with itraconazole.

Store below 30°C, away from light & in a dry place. Keep out of the reach of children.

Atropine is indicated for Non ulcer dyspepsia, Irritable bowel syndrome, Diverticular disease, Bradycardia, Organophosphorus poisoning, Premedication in anesthesia, Poisoning or overdosage with compound having muscarinic actions, Ophthalmic Inflammatory eye disorders, Eye refraction.

Anticholinergics (antimuscarinics)/ Anti-spasmodics, Mydriatic and Cycloplegic agents

Atropine binds to and inhibit muscarinic acetylcholine receptors, producing a wide range of anticholinergic effects. Atropine is an anticholinergic agent which competitively blocks the muscarinic receptors in peripheral tissues such as the heart, intestines, bronchial muscles, iris and secretory glands. Some central stimulation may occur. Atropine abolishes bradycardia and reduces heart block due to vagal activity. Smooth muscles in the bronchi and gut are relaxed while glandular secretions are reduced. It also has mydriatic and cycloplegic effect.

Adult:

• IV: Bradycardia: 500 mcg every 3-5 mins. Total: 3 mg.
• IV/IM: Organophosphorus poisoning: 2 mg every 10-30 mins until muscarinic effects disappear or atropine toxicity appears.
• IM/SC: Premedication in anesthesia: 300-600 mcg 30-60 mins before anesthesia.
• IV/IM/SC: Poisoning or overdosage with compound having muscarinic actions: 0.6-1 mg, repeat 2 hrly.
• Ophthalmic: Inflammatory eye disorders: As 0.5-1% solution: 1-2 drops 4 times/day.
• Ophthalmic: refraction: 1% solution 1 drop twice daily for 1-2 days before procedure.
• Oral: Non ulcer dyspepsia, Irritable bowel syndrome, Diverticular disease: 0.6-1.2 mg as a single dose at bedtime.

Usual Pediatric Dose for Anesthesia:

• 7 to 16 pounds: 0.1 mg, IV, IM, or subcutaneously
• 17 to 24 pounds: 0.15 mg, IV, IM, or subcutaneously
• 24 to 40 pounds: 0.2 mg, IV, IM, or subcutaneously
• 40 to 65 pounds: 0.3 mg, IV, IM, or subcutaneously
• 65 to 90 pounds: 0.4 mg, IV, IM, or subcutaneously
• Over 90 pounds: 0.4 to 0.6 mg, IV, IM, or subcutaneously

Injection: Dry mouth, dysphagia, constipation, flushing and dryness of skin, tachycardia, palpitations, arrhythmias, mydriasis, photophobia, cycloplegia, raised intraocular pressure. Toxic doses cause tachycardia, hyperpyrexia, restlessness, confusion, excitement, hallucinations, delirium and may progress to circulatory failure and resp depression.

Eye drops or ointment: Systemic toxicity esp in children, on prolonged use may lead to irritation, hyperaemia, oedema and conjunctivitis. Increased intraocular pressure.

Glaucoma, chronic respiratory disease, sick sinus syndrome, thyrotoxicosis, cardiac failure, pyloric stenosis, prostatic hypertrophy.

Reflux oesophagitis; elderly; infants and children; Pregnancy.

Additive anticholinergic effects with quinidine, antidepressants and some antihistamines.

Pregnancy Category C. Animal reproduction studies have not been conducted with atropine. It also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. Atropine should be given to a pregnant woman only if clearly needed.

May cause hyperthermia, hypertension, increased respiratory rate, nausea and vomiting. May also lead to CNS stimulation. Severe intoxication may lead to CNS depression, coma, respiratory failure and death.

Store atropine at room temperature between 20 to 25° C. Store away from heat, moisture, and light. Keep atropine out of the reach of children.

Anthelmintic

Ivermectin selectively binds and with high affinity to glutamate-gated chloride ion channels, which occur in invertebrate nerve and muscle cells leading to an increase in the permeability of cell membranes to chloride ions with hyperpolarization of the nerve or muscle cell and, ultimately, death of the parasite.

For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.

• Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
• Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
• Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
• Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
• Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
• Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg

Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.

Dosage Guidelines for Ivermectin for Strongyloidiasis:

• Body Weight (kg) 15-24: Dose 3 mg/kg
• Body Weight (kg) 25-35: Dose 6 mg/kg
• Body Weight (kg) 36-50: Dose 9 mg/kg
• Body Weight (kg) 51-65: Dose 12 mg/kg
• Body Weight (kg) 66-79: Dose 15 mg/kg
• Body Weight (kg) >80: Dose 200 mcg/kg

Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.

Dosage Guidelines for Ivermectin for Onchocerciasis:

• Body Weight (kg) 15-25: Dose 3 mg/kg
• Body Weight (kg) 26-44: Dose 6 mg/kg
• Body Weight (kg) 45-64: Dose 9 mg/kg
• Body Weight (kg) 65-84: Dose 12 mg/kg
• Body Weight (kg) >85: Dose 150 mcg/kg

Strongyloidiasis: In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to Ivermectin.

• Body as a whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
• Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
• Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).

Onchocerciasis: arthralgia/synovitis (19.3%), axillary lymph node enlargement and tenderness (11.0% and 4.4%, respectively), cervical lymph node enlargement and tenderness (5.3% and 1.2%, respectively), inguinal lymph node enlargement and tenderness (12.6% and 13.9%, respectively), other lymph node enlargement and tenderness (3.0% and 1.9%, respectively), pruritus (27.5%), skin involvement including edema, papular and pustular or frank urticarial rash (22.7%), and fever (22.6%), abnormal sensation in the eyes, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis. These have rarely been severe or associated with loss of vision and have generally resolved without corticosteroid treatment. The following adverse reactions have been reported since the drug was registered overseas: hypotension (mainly orthostatic hypotension), worsening of bronchial asthma, toxic epidermal necrolysis, and Stevens-Johnson syndrome.

It is contraindicated in patients who are hypersensitive to any component of this product.

Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis. Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: back pain, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, or coma.

Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.

Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.

Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn

Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.

Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.

Anthelmintic

Ivermectin selectively binds and with high affinity to glutamate-gated chloride ion channels, which occur in invertebrate nerve and muscle cells leading to an increase in the permeability of cell membranes to chloride ions with hyperpolarization of the nerve or muscle cell and, ultimately, death of the parasite.

For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.

• Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
• Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
• Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
• Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
• Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
• Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg

Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.

Dosage Guidelines for Ivermectin for Strongyloidiasis:

• Body Weight (kg) 15-24: Dose 3 mg/kg
• Body Weight (kg) 25-35: Dose 6 mg/kg
• Body Weight (kg) 36-50: Dose 9 mg/kg
• Body Weight (kg) 51-65: Dose 12 mg/kg
• Body Weight (kg) 66-79: Dose 15 mg/kg
• Body Weight (kg) >80: Dose 200 mcg/kg

Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.

Dosage Guidelines for Ivermectin for Onchocerciasis:

• Body Weight (kg) 15-25: Dose 3 mg/kg
• Body Weight (kg) 26-44: Dose 6 mg/kg
• Body Weight (kg) 45-64: Dose 9 mg/kg
• Body Weight (kg) 65-84: Dose 12 mg/kg
• Body Weight (kg) >85: Dose 150 mcg/kg

Strongyloidiasis: In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to Ivermectin.

• Body as a whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
• Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
• Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).

Onchocerciasis: arthralgia/synovitis (19.3%), axillary lymph node enlargement and tenderness (11.0% and 4.4%, respectively), cervical lymph node enlargement and tenderness (5.3% and 1.2%, respectively), inguinal lymph node enlargement and tenderness (12.6% and 13.9%, respectively), other lymph node enlargement and tenderness (3.0% and 1.9%, respectively), pruritus (27.5%), skin involvement including edema, papular and pustular or frank urticarial rash (22.7%), and fever (22.6%), abnormal sensation in the eyes, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis. These have rarely been severe or associated with loss of vision and have generally resolved without corticosteroid treatment. The following adverse reactions have been reported since the drug was registered overseas: hypotension (mainly orthostatic hypotension), worsening of bronchial asthma, toxic epidermal necrolysis, and Stevens-Johnson syndrome.

It is contraindicated in patients who are hypersensitive to any component of this product.

Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis. Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: back pain, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, or coma.

Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.

Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.

Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn

Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.

Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.

Anthelmintic

Ivermectin selectively binds and with high affinity to glutamate-gated chloride ion channels, which occur in invertebrate nerve and muscle cells leading to an increase in the permeability of cell membranes to chloride ions with hyperpolarization of the nerve or muscle cell and, ultimately, death of the parasite.

For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.

• Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
• Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
• Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
• Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
• Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
• Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg

Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.

Dosage Guidelines for Ivermectin for Strongyloidiasis:

• Body Weight (kg) 15-24: Dose 3 mg/kg
• Body Weight (kg) 25-35: Dose 6 mg/kg
• Body Weight (kg) 36-50: Dose 9 mg/kg
• Body Weight (kg) 51-65: Dose 12 mg/kg
• Body Weight (kg) 66-79: Dose 15 mg/kg
• Body Weight (kg) >80: Dose 200 mcg/kg

Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.

Dosage Guidelines for Ivermectin for Onchocerciasis:

• Body Weight (kg) 15-25: Dose 3 mg/kg
• Body Weight (kg) 26-44: Dose 6 mg/kg
• Body Weight (kg) 45-64: Dose 9 mg/kg
• Body Weight (kg) 65-84: Dose 12 mg/kg
• Body Weight (kg) >85: Dose 150 mcg/kg

Strongyloidiasis: In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to Ivermectin.

• Body as a whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
• Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
• Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).

Onchocerciasis: arthralgia/synovitis (19.3%), axillary lymph node enlargement and tenderness (11.0% and 4.4%, respectively), cervical lymph node enlargement and tenderness (5.3% and 1.2%, respectively), inguinal lymph node enlargement and tenderness (12.6% and 13.9%, respectively), other lymph node enlargement and tenderness (3.0% and 1.9%, respectively), pruritus (27.5%), skin involvement including edema, papular and pustular or frank urticarial rash (22.7%), and fever (22.6%), abnormal sensation in the eyes, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis. These have rarely been severe or associated with loss of vision and have generally resolved without corticosteroid treatment. The following adverse reactions have been reported since the drug was registered overseas: hypotension (mainly orthostatic hypotension), worsening of bronchial asthma, toxic epidermal necrolysis, and Stevens-Johnson syndrome.

It is contraindicated in patients who are hypersensitive to any component of this product.

Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis. Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: back pain, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, or coma.

Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.

Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.

Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn

Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.

Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.

Anthelmintic

Ivermectin selectively binds and with high affinity to glutamate-gated chloride ion channels, which occur in invertebrate nerve and muscle cells leading to an increase in the permeability of cell membranes to chloride ions with hyperpolarization of the nerve or muscle cell and, ultimately, death of the parasite.

For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.

• Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
• Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
• Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
• Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
• Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
• Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg

Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.

Dosage Guidelines for Ivermectin for Strongyloidiasis:

• Body Weight (kg) 15-24: Dose 3 mg/kg
• Body Weight (kg) 25-35: Dose 6 mg/kg
• Body Weight (kg) 36-50: Dose 9 mg/kg
• Body Weight (kg) 51-65: Dose 12 mg/kg
• Body Weight (kg) 66-79: Dose 15 mg/kg
• Body Weight (kg) >80: Dose 200 mcg/kg

Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.

Dosage Guidelines for Ivermectin for Onchocerciasis:

• Body Weight (kg) 15-25: Dose 3 mg/kg
• Body Weight (kg) 26-44: Dose 6 mg/kg
• Body Weight (kg) 45-64: Dose 9 mg/kg
• Body Weight (kg) 65-84: Dose 12 mg/kg
• Body Weight (kg) >85: Dose 150 mcg/kg

Strongyloidiasis: In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to Ivermectin.

• Body as a whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
• Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
• Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).

Onchocerciasis: arthralgia/synovitis (19.3%), axillary lymph node enlargement and tenderness (11.0% and 4.4%, respectively), cervical lymph node enlargement and tenderness (5.3% and 1.2%, respectively), inguinal lymph node enlargement and tenderness (12.6% and 13.9%, respectively), other lymph node enlargement and tenderness (3.0% and 1.9%, respectively), pruritus (27.5%), skin involvement including edema, papular and pustular or frank urticarial rash (22.7%), and fever (22.6%), abnormal sensation in the eyes, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis. These have rarely been severe or associated with loss of vision and have generally resolved without corticosteroid treatment. The following adverse reactions have been reported since the drug was registered overseas: hypotension (mainly orthostatic hypotension), worsening of bronchial asthma, toxic epidermal necrolysis, and Stevens-Johnson syndrome.

It is contraindicated in patients who are hypersensitive to any component of this product.

Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis. Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: back pain, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, or coma.

Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.

Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.

Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn

Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.

Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.

Ibandronic acid is indicated for the treatment of postmenopausal osteoporosis, to reduce the risk of fractures.

Treatment of Osteoporosis: Osteoporosis may be confirmed by the finding of low bone mass (T-score <-2.0 SD) and the presence or history of osteoporotic fracture, or a low bone mass (T-score <-2.5 SD) in the absence of documented pre-existing osteoporotic fracture.

Bisphosphonate preparations

The pharmacodynamic action of ibandronic acid is inhibition of bone resorption. In vivo, ibandronic acid prevents experimentally induced bone destruction caused by cessation of gonadal function, retinoids, tumors or tumor extracts. In young (fast growing) rats, the endogenous bone resorption is also inhibited, leading to increased bone mass compared with untreated animals. Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity. In growing rats, there was no evidence of impaired mineralization even at doses greater than 5,000 times the dose required for osteoporosis treatment. The high potency and therapeutic margin of ibandronic acid allows for more flexible dosing regimens and intermittent treatment with long drug-free intervals at comparatively low doses.

Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act on bone tissue and specifically inhibit osteoclast activity, It does not interfere with osteoclast recruitment. The selective action of ibandronic acid on bone tissue is based on the high affinity of this compound for hydroxyapatite, which represents the mineral matrix of the bone. Ibandronic acid reduces bone resorption, with no direct effect on bone formation. In postmenopausal women, it reduces the elevated rate of bone turnover towards premenopausal levels, leading to a progressive net gain in bone mass. Daily or intermittent administration of ibandronic acid results in reduced bone resorption as reflected in reduced levels of serum and urinary biochemical markers of bone turnover, increased BMD and a decreased incidence of fractures.

The recommended dose of Ibandronic acid for treatment is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month. Ibandronic acid should be taken 60 minutes before the first food or drink (other than water) of the day or any other oral medication or supplementation (including calcium):

• Tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position. Patients should not lie down for 60 minutes after taking Ibandronic acid.
• Plain water is the only drink that should be taken with Ibandronic acid. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
• Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration. Patients should receive supplemental calcium or vitamin D if dietary intake is inadequate. In case a once-monthly dose is missed, patients should be instructed to take one Ibandronic Acid 150 mg tablet the morning after the tablet is remembered unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their dose once a month on their originally scheduled date. If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled. Patients should not take two 150 mg tablets within the same week.

The main side effects of ibandronic acid are dyspepsia, nausea, diarrhea, abdominal pain, muscle aches, headaches, dizziness.

Ibandronic Acid is contraindicated in patients with known hypersensitivity to ibandronic acid or to any of the excipients. Ibandronic Acid is contraindicated in patients with uncorrected hypocalcemia. As with all bisphosphonates indicated in the treatment of osteoporosis, pre-existing hypocalcemia needs to be corrected before initiating therapy with Ibandronic Acid. As with several bisphosphonates, Ibandronic Acid is contraindicated in patients with abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Ibandronic Acid is contraindicated in patients who are unable to stand or sit upright for at least 60 minutes.

Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic Acid therapy. Adequate intake of calcium and vitamin D is important in all patients. Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic Acid is given to patients with active upper gastrointestinal problems (e.g. known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers). Adverse experiences such as esophagitis, esophageal ulcers and esophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. The risk of severe esophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Patients should pay particular attention and be able to comply with the dosing instructions.

Physicians should be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Ibandronic Acid and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications. Since NSAIDs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant medication with Ibandronic Acid. Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis of the jaw include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), and co-morbid disorders (e.g., anemia, coagulopathy, infection, pre-existing dental disease). Most reported cases have been in patients treated with bisphosphonates intravenously but some have been in patients treated orally. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit-risk assessment.

It is likely that calcium supplements, antacids and some oral medications containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Ibandronic Acid. Therefore, patients must wait 60 minutes after taking Ibandronic Acid before taking other oral medications. Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (estrogen). No interaction was observed when co-administered with melphalan/prednisolone in patients with multiple myeloma. In healthy male volunteers and postmenopausal women, i.v. ranitidine caused an increase in ibandronic acid bioavailability of about 20 %, probably as a result of reduced gastric acidity. However, since this increase is within the normal range of the bioavailability of ibandronic acid, no dosage adjustment is required when Ibandronic Acid is administered with H2-antagonists or other drugs which increase gastric pH.

In relation to disposition, no drug interactions of clinical significance are considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats. Furthermore, plasma protein binding is low at therapeutic concentrations and ibandronic acid is therefore unlikely to displace other drugs. Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation. The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other drugs. In a one-year study in postmenopausal women with osteoporosis (BM16549). the incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking Ibandronic Acid 2.5 mg daily or 150mg once monthly. Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% of patients used histamine (H2) blockers or proton pump inhibitors. Among these patients, the incidence of upper gastrointestinal events in the patients treated with Ibandronic Acid 150 mg once monthly was similar to that in patients treated with Ibandronic Acid 2.5 mg daily.

Pregnancy: Ibandronic Acid should not be used during pregnancy. There was no evidence for a direct fetal toxic or teratogenic effect of ibandronic acid in daily orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats. Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class. They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome). Specific studies for the monthly regimen have not been performed. There is no clinical experience with Ibandronic Acid in pregnant women.

Nursing Mothers: Ibandronic Acid should not be used during lactation. In lactating rats treated with 0.08 mg/kg/day IV. ibandronic acid, the highest concentration of ibandronic acid in breast milk was 8.1 ng/ml and was seen in the first 2 hours after i.v. administration. After 24 hours, the concentration in milk and plasma was similar, and corresponded to about 5 % of the concentration measured after 2 hours.

No specific information is available on the treatment of overdosage with ibandronic acid. However, oral overdosage may result in upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer. Milk or antacids should be given to bind ibandronic acid. Owing to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated:

• In patients unable to tolerate or with a contra-indication to the use of beta-blockers or
• In combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm.

Other Anti-anginal & Anti-ischaemic drugs

Ivabradine is a pure heart rate lowering agent. It acts by selective and specific inhibition of the cardiac pacemaker I f current that controls the spontaneous diastolic depolarization in the sinus node and regulates heart rate. By decreasing heart rate, Ivabradine decreases the cardiac workload and therefore oxygen consumption. Concomitantly, Ivabradine prolongs diastole allowing increased perfusion of coronary arteries and increased oxygen supply to the heart. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarization.

Adult: The usual recommended starting dose of Ivabradine is 5 mg twice daily which may be increased after 3-4 weeks of treatment to 7.5 mg twice daily, depending on therapeutic response. Usual dose is 1 tablet in the morning and 1 tablet in the evening during meals. If the heart rate decreases persistently below 50 bpm at rest or if symptoms related to bradycardia, the dose must be adjusted downwards to 2.5 mg twice daily (one half of the 5 mg tablet twice daily). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist.

Elderly: Consider a lower starting dose (2.5 mg twice daily i.e. one half 5 mg tablet twice daily).

Visual symptoms, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, and dizziness.

History of hypersensitivity to Ivabradine or any of the excipients, resting heart rate below 60 bpm before treatment, cardiogenic shock, acute myocardial infarction, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, heart failure, pacemaker dependent, unstable angina, 3^rd degree AV block, combination with strong cytochrome P-450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics, HIV protease inhibitors).

Mild to moderate hypotension, atrial fibrillation, patients with congenital QT syndrome or treated with QT wave prolonging medicinal products, Moderate hepatic insufficiency, severe renal insufficiency.

QT wave prolonging medicinal products is not recommended. Cardiovascular QT wave prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone). Non cardiovascular QT wave prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin). The concomitant use of cardiovascular and non cardiovascular QT wave prolonging medicinal products with ivabradine should be avoided since QT wave prolongation may be exacerbated by heart rate reduction. If the combination appears necessary, close cardiac monitoring is needed.

Studies in rats have shown no effect on fertility in males and females. There are no or limited amount of data from the use of ivabradine in pregnant women. Therefore, ivabradine is contra indicated during pregnancy. Animal studies indicate that ivabradine is excreted in milk. Therefore, ivabradine is contra-indicated during breast-feeding.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated:

• In patients unable to tolerate or with a contra-indication to the use of beta-blockers or
• In combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm.

Other Anti-anginal & Anti-ischaemic drugs

Ivabradine is a pure heart rate lowering agent. It acts by selective and specific inhibition of the cardiac pacemaker I f current that controls the spontaneous diastolic depolarization in the sinus node and regulates heart rate. By decreasing heart rate, Ivabradine decreases the cardiac workload and therefore oxygen consumption. Concomitantly, Ivabradine prolongs diastole allowing increased perfusion of coronary arteries and increased oxygen supply to the heart. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarization.

Adult: The usual recommended starting dose of Ivabradine is 5 mg twice daily which may be increased after 3-4 weeks of treatment to 7.5 mg twice daily, depending on therapeutic response. Usual dose is 1 tablet in the morning and 1 tablet in the evening during meals. If the heart rate decreases persistently below 50 bpm at rest or if symptoms related to bradycardia, the dose must be adjusted downwards to 2.5 mg twice daily (one half of the 5 mg tablet twice daily). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist.

Elderly: Consider a lower starting dose (2.5 mg twice daily i.e. one half 5 mg tablet twice daily).

Visual symptoms, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, and dizziness.

History of hypersensitivity to Ivabradine or any of the excipients, resting heart rate below 60 bpm before treatment, cardiogenic shock, acute myocardial infarction, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, heart failure, pacemaker dependent, unstable angina, 3^rd degree AV block, combination with strong cytochrome P-450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics, HIV protease inhibitors).

Mild to moderate hypotension, atrial fibrillation, patients with congenital QT syndrome or treated with QT wave prolonging medicinal products, Moderate hepatic insufficiency, severe renal insufficiency.

QT wave prolonging medicinal products is not recommended. Cardiovascular QT wave prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone). Non cardiovascular QT wave prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin). The concomitant use of cardiovascular and non cardiovascular QT wave prolonging medicinal products with ivabradine should be avoided since QT wave prolongation may be exacerbated by heart rate reduction. If the combination appears necessary, close cardiac monitoring is needed.

Studies in rats have shown no effect on fertility in males and females. There are no or limited amount of data from the use of ivabradine in pregnant women. Therefore, ivabradine is contra indicated during pregnancy. Animal studies indicate that ivabradine is excreted in milk. Therefore, ivabradine is contra-indicated during breast-feeding.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated:

• In patients unable to tolerate or with a contra-indication to the use of beta-blockers or
• In combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm.

Other Anti-anginal & Anti-ischaemic drugs

Ivabradine is a pure heart rate lowering agent. It acts by selective and specific inhibition of the cardiac pacemaker I f current that controls the spontaneous diastolic depolarization in the sinus node and regulates heart rate. By decreasing heart rate, Ivabradine decreases the cardiac workload and therefore oxygen consumption. Concomitantly, Ivabradine prolongs diastole allowing increased perfusion of coronary arteries and increased oxygen supply to the heart. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarization.

Adult: The usual recommended starting dose of Ivabradine is 5 mg twice daily which may be increased after 3-4 weeks of treatment to 7.5 mg twice daily, depending on therapeutic response. Usual dose is 1 tablet in the morning and 1 tablet in the evening during meals. If the heart rate decreases persistently below 50 bpm at rest or if symptoms related to bradycardia, the dose must be adjusted downwards to 2.5 mg twice daily (one half of the 5 mg tablet twice daily). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist.

Elderly: Consider a lower starting dose (2.5 mg twice daily i.e. one half 5 mg tablet twice daily).

Visual symptoms, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, and dizziness.

History of hypersensitivity to Ivabradine or any of the excipients, resting heart rate below 60 bpm before treatment, cardiogenic shock, acute myocardial infarction, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, heart failure, pacemaker dependent, unstable angina, 3^rd degree AV block, combination with strong cytochrome P-450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics, HIV protease inhibitors).

Mild to moderate hypotension, atrial fibrillation, patients with congenital QT syndrome or treated with QT wave prolonging medicinal products, Moderate hepatic insufficiency, severe renal insufficiency.

QT wave prolonging medicinal products is not recommended. Cardiovascular QT wave prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone). Non cardiovascular QT wave prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin). The concomitant use of cardiovascular and non cardiovascular QT wave prolonging medicinal products with ivabradine should be avoided since QT wave prolongation may be exacerbated by heart rate reduction. If the combination appears necessary, close cardiac monitoring is needed.

Studies in rats have shown no effect on fertility in males and females. There are no or limited amount of data from the use of ivabradine in pregnant women. Therefore, ivabradine is contra indicated during pregnancy. Animal studies indicate that ivabradine is excreted in milk. Therefore, ivabradine is contra-indicated during breast-feeding.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated:

• In patients unable to tolerate or with a contra-indication to the use of beta-blockers or
• In combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm.

Other Anti-anginal & Anti-ischaemic drugs

Ivabradine is a pure heart rate lowering agent. It acts by selective and specific inhibition of the cardiac pacemaker I f current that controls the spontaneous diastolic depolarization in the sinus node and regulates heart rate. By decreasing heart rate, Ivabradine decreases the cardiac workload and therefore oxygen consumption. Concomitantly, Ivabradine prolongs diastole allowing increased perfusion of coronary arteries and increased oxygen supply to the heart. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarization.

Adult: The usual recommended starting dose of Ivabradine is 5 mg twice daily which may be increased after 3-4 weeks of treatment to 7.5 mg twice daily, depending on therapeutic response. Usual dose is 1 tablet in the morning and 1 tablet in the evening during meals. If the heart rate decreases persistently below 50 bpm at rest or if symptoms related to bradycardia, the dose must be adjusted downwards to 2.5 mg twice daily (one half of the 5 mg tablet twice daily). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist.

Elderly: Consider a lower starting dose (2.5 mg twice daily i.e. one half 5 mg tablet twice daily).

Visual symptoms, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, and dizziness.

History of hypersensitivity to Ivabradine or any of the excipients, resting heart rate below 60 bpm before treatment, cardiogenic shock, acute myocardial infarction, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, heart failure, pacemaker dependent, unstable angina, 3^rd degree AV block, combination with strong cytochrome P-450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics, HIV protease inhibitors).

Mild to moderate hypotension, atrial fibrillation, patients with congenital QT syndrome or treated with QT wave prolonging medicinal products, Moderate hepatic insufficiency, severe renal insufficiency.

QT wave prolonging medicinal products is not recommended. Cardiovascular QT wave prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone). Non cardiovascular QT wave prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin). The concomitant use of cardiovascular and non cardiovascular QT wave prolonging medicinal products with ivabradine should be avoided since QT wave prolongation may be exacerbated by heart rate reduction. If the combination appears necessary, close cardiac monitoring is needed.

Studies in rats have shown no effect on fertility in males and females. There are no or limited amount of data from the use of ivabradine in pregnant women. Therefore, ivabradine is contra indicated during pregnancy. Animal studies indicate that ivabradine is excreted in milk. Therefore, ivabradine is contra-indicated during breast-feeding.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated:

• In patients unable to tolerate or with a contra-indication to the use of beta-blockers or
• In combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm.

Other Anti-anginal & Anti-ischaemic drugs

Ivabradine is a pure heart rate lowering agent. It acts by selective and specific inhibition of the cardiac pacemaker I f current that controls the spontaneous diastolic depolarization in the sinus node and regulates heart rate. By decreasing heart rate, Ivabradine decreases the cardiac workload and therefore oxygen consumption. Concomitantly, Ivabradine prolongs diastole allowing increased perfusion of coronary arteries and increased oxygen supply to the heart. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarization.

Adult: The usual recommended starting dose of Ivabradine is 5 mg twice daily which may be increased after 3-4 weeks of treatment to 7.5 mg twice daily, depending on therapeutic response. Usual dose is 1 tablet in the morning and 1 tablet in the evening during meals. If the heart rate decreases persistently below 50 bpm at rest or if symptoms related to bradycardia, the dose must be adjusted downwards to 2.5 mg twice daily (one half of the 5 mg tablet twice daily). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist.

Elderly: Consider a lower starting dose (2.5 mg twice daily i.e. one half 5 mg tablet twice daily).

Visual symptoms, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, and dizziness.

History of hypersensitivity to Ivabradine or any of the excipients, resting heart rate below 60 bpm before treatment, cardiogenic shock, acute myocardial infarction, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, heart failure, pacemaker dependent, unstable angina, 3^rd degree AV block, combination with strong cytochrome P-450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics, HIV protease inhibitors).

Mild to moderate hypotension, atrial fibrillation, patients with congenital QT syndrome or treated with QT wave prolonging medicinal products, Moderate hepatic insufficiency, severe renal insufficiency.

QT wave prolonging medicinal products is not recommended. Cardiovascular QT wave prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone). Non cardiovascular QT wave prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin). The concomitant use of cardiovascular and non cardiovascular QT wave prolonging medicinal products with ivabradine should be avoided since QT wave prolongation may be exacerbated by heart rate reduction. If the combination appears necessary, close cardiac monitoring is needed.

Studies in rats have shown no effect on fertility in males and females. There are no or limited amount of data from the use of ivabradine in pregnant women. Therefore, ivabradine is contra indicated during pregnancy. Animal studies indicate that ivabradine is excreted in milk. Therefore, ivabradine is contra-indicated during breast-feeding.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated:

• In patients unable to tolerate or with a contra-indication to the use of beta-blockers or
• In combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm.

Other Anti-anginal & Anti-ischaemic drugs

Ivabradine is a pure heart rate lowering agent. It acts by selective and specific inhibition of the cardiac pacemaker I f current that controls the spontaneous diastolic depolarization in the sinus node and regulates heart rate. By decreasing heart rate, Ivabradine decreases the cardiac workload and therefore oxygen consumption. Concomitantly, Ivabradine prolongs diastole allowing increased perfusion of coronary arteries and increased oxygen supply to the heart. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarization.

Adult: The usual recommended starting dose of Ivabradine is 5 mg twice daily which may be increased after 3-4 weeks of treatment to 7.5 mg twice daily, depending on therapeutic response. Usual dose is 1 tablet in the morning and 1 tablet in the evening during meals. If the heart rate decreases persistently below 50 bpm at rest or if symptoms related to bradycardia, the dose must be adjusted downwards to 2.5 mg twice daily (one half of the 5 mg tablet twice daily). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist.

Elderly: Consider a lower starting dose (2.5 mg twice daily i.e. one half 5 mg tablet twice daily).

Visual symptoms, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, and dizziness.

History of hypersensitivity to Ivabradine or any of the excipients, resting heart rate below 60 bpm before treatment, cardiogenic shock, acute myocardial infarction, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, heart failure, pacemaker dependent, unstable angina, 3^rd degree AV block, combination with strong cytochrome P-450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics, HIV protease inhibitors).

Mild to moderate hypotension, atrial fibrillation, patients with congenital QT syndrome or treated with QT wave prolonging medicinal products, Moderate hepatic insufficiency, severe renal insufficiency.

QT wave prolonging medicinal products is not recommended. Cardiovascular QT wave prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone). Non cardiovascular QT wave prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin). The concomitant use of cardiovascular and non cardiovascular QT wave prolonging medicinal products with ivabradine should be avoided since QT wave prolongation may be exacerbated by heart rate reduction. If the combination appears necessary, close cardiac monitoring is needed.

Studies in rats have shown no effect on fertility in males and females. There are no or limited amount of data from the use of ivabradine in pregnant women. Therefore, ivabradine is contra indicated during pregnancy. Animal studies indicate that ivabradine is excreted in milk. Therefore, ivabradine is contra-indicated during breast-feeding.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.