Milast-A 500 mcg (Tablet)

Indications

• Maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis
• Adult patients with a history of frequent exacerbations

Pharmacology

• Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor
• Potential anti-inflammatory and antimodulatory effects in the pulmonary system
• Therapeutic actions due to increased levels of intracellular cyclic AMP

Dosage & Administration

• Recommended dose of 500 micrograms Roflumilast once daily
• May need to be taken for several weeks to achieve its effect
• Studied in clinical trials for up to one year
• No dose adjustment for elderly and renal impairment
• Caution advised in patients with mild hepatic impairment
• Not recommended for pediatric use
• Tablet should be swallowed with water and taken at the same time every day

Interaction

• No proven cases of hazardous interactions
• Case report of interaction with ethanol and compound containing pyrimethamine with dapsone
• Potentiation of betahistine with salbutamol

Contraindications

• Hypersensitivity to Roflumilast or to any of the excipients
• Moderate or severe hepatic impairment

Side Effects

• Adverse reactions including diarrhoea, weight decrease, nausea, abdominal pain, and headache
• Majority of adverse reactions were mild or moderate
• Mostly resolved on continued treatment
• Adverse reactions mainly occurred within the first weeks of therapy
• Multiple adverse reactions under different MedDRA frequency classifications
• Rare instances of gynaecomastia, suicidal ideation and behavior, and dysgeusia observed

Pregnancy & Lactation

• Not recommended during pregnancy and in women of childbearing potential not using contraception
• Crosses the placenta in pregnant rats
• Should not be used during breastfeeding

Precautions & Warnings

• Not indicated for relief of acute bronchospasms
• Increased risk of psychiatric disorders
• Discontinuation recommended in case of new or worsening psychiatric symptoms
• Treatment should be reassessed in case of persistent intolerability
• Concomitant treatment with theophylline not recommended
• Contains lactose, not suitable for patients with rare hereditary problems

Overdose Effects

• Symptoms observed at increased rates after single oral doses of 2,500 and 5,000 micrograms
• Appropriate supportive medical care recommended in case of overdose
• Haemodialysis is not likely to be efficient for removal

Therapeutic Class

• Antihistamines anti-allergies & hypo-sensitisation

Storage Conditions

• Store below 30°C
• Keep away from light and moisture
• Keep out of the reach of children

Related Brands

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• Rofumil 500 mcg (Tablet) - drug-international-ltd