Arifam Uses

• Arifam indications
• Arifam description
• Arifam dosage
• Arifam interactions
• Arifam side effects
• Arifam contraindications

Arifam indications

Arifam is indicated as substitution therapy for treatment of essential hypertension in patients already controlled with Indapamide (Arifam) and Amlodipine (Arifam) given concurrently at the same dose level.

Arifam description

Excipients: Excipient with Known Effect: Lactose monohydrate 104.5 mg. Tablet Core: Hypromellose (E464), lactose monohydrate, magnesium stearate (E572), povidone (E1201), silica colloidal anhydrous, calcium hydrogen phosphate dihydrate, cellulose, microcrystalline (E460), croscarmellose sodium (E468), pregelatinized maize starch.

Tablet Film-Coating: Arifam 1.5 mg/5 mg: Glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E572), titanium dioxide (E171). Arifam 1.5 mg/10 mg: Glycerol (E422), hypromellose (E464), iron oxide red (E172), macrogol 6000, magnesium stearate (E572), titanium dioxide (E171).

Arifam dosage

One tablet per day as single dose, preferably to be taken in the morning, to be swallowed whole with water and not chewed.

The fixed dose combination is not suitable for initiation therapy.

If a change of the posology is required, titration should be done with the individual components.

Special Populations: Paediatric Population: The safety and efficacy of Arifam in children and adolescents have not been established. No data are available.

Patients with Renal Impairment : In severe renal impairment (creatinine clearance <30 mL/min), treatment is contraindicated. In patients with mild to moderate renal impairment, no dose adjustment is needed.

Older People : Older people can be treated with Arifam according to renal function.

Patients with Hepatic Impairment : In severe hepatic impairment, treatment is contraindicated.

Dosage recommendations of Amlodipine (Arifam) have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range.

Administration:

Oral administration.

Arifam interactions

Do not take: With lithium (used to treat mental disorders such as mania, manic depression illness and recurrent depression) due to the risk of increased levels of lithium in the blood; with dantrolene (infusion for severe body temperature abnormalities).

Special Care: Other medicines for treating high blood pressure; medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide); medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotic drugs, neuroleptics); bepridil (used to treat angina pectoris, a condition causing chest pain); cisapride, diphemanil (used to treat gastrointestinal problems); sparfloxacin, moxifloxacin, erythromycin by injection (antibiotics used to treat infections); vincamine IV (used to treat symptomatic cognitive disorders in elderly including memory loss); halofantrine (antiparasitic drug used to treat certain types of malaria); pentamidine (used to treat certain types of pneumonia); mizolastine (used to treat allergic reactions, such as hay fever); non-steroidal anti-inflammatory drugs for pain relief (e.g. ibuprofen) or high doses of acetylsalicyclic acid; angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure); oral corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis; digitalis preparations (for the treatment of heart problems); stimulant laxatives; baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis); potassium-sparing diuretics (amiloride, spironolactone, triamterene); metformin (to treat diabetes); iodinated contrast media (used for tests involving x-rays); calcium tablets or other calcium supplements; ciclosporin, tacrolimus or other medicines to depress the immune system after organ transplantation, to treat autoimmune diseases, or severe rheumatic or dermatological diseases; tetracosactide (to treat Crohn's disease); ketoconazole, itraconazole, amphotericin B by injection (anti-fungal medicines); ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV); rifampicin, erythromycin, clarithromycin (antibiotics); Hypericum perforatum (St. John's wort); verapamil, diltiazem (heart medicines); simvastatin, an agent used to lower levels of cholesterol and fats (triglycerides) in the blood; and allopurinol (to treat gout).

Arifam side effects

Summary of the Safety Profile: The most commonly reported adverse reactions with Indapamide (Arifam) and Amlodipine (Arifam) given separately are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.

Tabulated List of Adverse Reactions: The following adverse reactions have been observed and reported during treatment with Indapamide (Arifam) and Amlodipine (Arifam) with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known (cannot be estimated from the available data)..

Exceptional cases of extrapyramidal syndrome have been reported with Amlodipine (Arifam).

Reporting of Suspected Adverse Reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Arifam contraindications

Do not take: If allergic to Indapamide (Arifam) or any other sulfonamide, or to Amlodipine (Arifam) or any other calcium antagonist or to any of the other ingredients of this medicine, symptoms include itching, reddening of the skin or difficulty in breathing; if the patient has severe low blood pressure (hypotension); narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body); if the patient suffers from heart failure after a heart attack; severe kidney disease; severe liver disease or suffer from hepatic encephalopathy (disease of the brain caused by liver illness); low potassium levels in the blood; and if the patient is breastfeeding.

Active ingredient matches for Arifam:

Amlodipine/Indapamide in Georgia.

References

1. DailyMed. "INDAPAMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "indapamide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. PubChem. "amlodipine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology