Products Description

SAFETY ALERT Contraindications (CI): Concomitant use with nelfinavir or rilpivirine. Special Precautions (SP): Patients with reduced body stores or risk factors for reduced vitamin B$_{12}$ absorption are at risk of osteoporosis-related fractures. Exercise caution in cases of hepatic and severe renal impairment, in children, during pregnancy, and lactation. Monitoring Parameters: Regularly monitor serum magnesium (especially when used with agents that may cause hypomagnesaemia) and calcium levels in at-risk patients (e.g., hypoparathyroidism) at baseline and periodically thereafter. Monitor for rebleeding in patients with peptic ulcer bleed. Further follow-up and diagnostic testing should be considered in patients with suboptimal response or early symptomatic relapse following H. pylori eradication. Delay in diagnosing malignancy should be avoided in cases of any alarm symptoms, such as significant unintentional weight loss, recurrent vomiting, dysphagia, melaena, or haematemesis. Drug Interactions (INT): This medication may decrease the exposure and efficacy of atazanavir and may diminish the therapeutic efficacy of bosentan. There is an increased risk of hypomagnesaemia with digoxin or diuretics. It may increase the serum concentrations of saquinavir, tacrolimus, methotrexate, citalostad, and drugs metabolized by CYP2C19 (e.g., diazepam, citalopram, imipramine, phenytoin). It may also decrease the absorption of agents dependent on gastric pH for absorption (e.g., ketoconazole, itraconazole, iron salts, erlotinib, dasatinib, mycophenolate). Concomitant use with warfarin may increase INR and prothrombin time. Esomeprazole serum levels may be decreased with CYP2C19 and/or CYP3A4 inducers (e.g., rifampicin) and increased with CYP3A4 inhibitors (e.g., clarithromycin) or combined inhibitors of CYP2C19 & CYP3A4 (e.g., voriconazole). It may prolong the elimination half-life of cilostazol and decrease the serum levels of nelfinavir or rilpivirine, which may lead to loss of virological effect and development of drug resistance. Adverse Drug Reactions (ADR): Symptoms: Hypomagnesaemia (with prolonged use), and osteoporosis-related fractures of the hip, wrist, and spine (particularly with high doses & prolonged use). May increase the risk of Clostridium difficile-associated diarrhoea. GI Infections: (e.g., Salmonella, Campylobacter); fungal infections, polyps, acute tubulointerstitial nephritis; vitamin B$_{12}$ deficiency (prolonged use), subacute cutaneous lupus erythematosus (SCLE), SLE. Blood & Lymphatic System Disorders: Rarely, leucopenia, thrombocytopenia. Eye & Ear Disorders: Vertigo. Eye Disorders: Rarely, blurred vision. Gastrointestinal Disorders: Nausea, vomiting, constipation, diarrhoea, abdominal pain, flatulence, dry mouth. General Disorders & Administration Site Conditions: Injection site reactions (IV). Rarely, malaise, peripheral oedema. Hepatobiliary Disorders: Rarely, hepatitis with or without jaundice. Immune System Disorders: Rarely, hypersensitivity reactions (e.g., fever, angioedema, anaphylactic reaction/shock). Investigations: Increased liver enzymes. Metabolism & Nutrition Disorders: Peripheral oedema. Rarely, hyponatraemia. Musculoskeletal & Connective Tissue Disorders: Rarely, myalgia, arthralgia. Nervous System Disorders: Headache, dizziness, somnolence, paraesthesia. Psychiatric Disorders: Insomnia. Rarely, agitation, depression. Reproductive System & Breast Disorders: Very rarely, gynecomastia. Respiratory, Thoracic & Mediastinal Disorders: Rarely, bronchospasm. Skin & Subcutaneous Tissue Disorders: Dermatitis, pruritus, rash, urticaria. Rarely, alopecia, photosensitivity. Very rarely, severe cutaneous reactions.

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