Milast-A500 mcg

Description

Indications
Milast-A is prescribed for the long-term management of severe chronic obstructive pulmonary disease (COPD) in adults, particularly those with chronic bronchitis who have a history of frequent exacerbations. It is used as an additional therapy alongside bronchodilator treatment.
Take this medication as per the advice of a registered physician.

Pharmacology
Roflumilast functions as a selective phosphodiesterase-4 (PDE-4) inhibitor, which helps regulate inflammatory responses within the lungs. By inhibiting the PDE4 isoenzyme, it increases intracellular cyclic AMP levels, leading to its anti-inflammatory and immunomodulatory effects, contributing to improved pulmonary function.

Dosage & Administration
The recommended dose for adults is one 500-microgram tablet of Roflumilast taken once daily. It may take several weeks of consistent use before noticeable therapeutic effects are achieved. Clinical studies have assessed Roflumilast over treatment durations of up to one year.

• Elderly (65 years and older): No dose adjustment required.
• Renal impairment: No dose adjustment necessary.
• Hepatic impairment: Use with caution in patients with mild hepatic impairment (Child-Pugh A) due to limited clinical data. Patients with moderate to severe hepatic impairment (Child-Pugh B or C) should not take Roflumilast.
• Pediatric population: Not intended for use in individuals under 18 years.
• The tablet should be swallowed whole with water at the same time daily, with or without food.
  Take this medication as per the advice of a registered physician.

Interaction
There are no well-established hazardous interactions. However, isolated reports suggest potential interactions with ethanol and certain compounds containing pyrimethamine with dapsone. Additionally, the concurrent use of betahistine with salbutamol may enhance the effects of betahistine, as it is a histamine analogue. Concurrent use of H1 antagonists may result in mutual attenuation of effects between active agents.

Contraindications

• Known hypersensitivity to Roflumilast or any of its excipients.
• Moderate to severe hepatic impairment.

Side Effects
In clinical trials involving COPD patients, approximately 16% of individuals reported adverse reactions compared to 5% in placebo-treated patients. The most frequently observed side effects include:

• Common: Diarrhea (5.9%), weight loss (3.4%), nausea (2.9%), abdominal pain (1.9%), headache (1.7%).
• Uncommon: Hypersensitivity reactions, tremors, vertigo, palpitations, skin rashes.
• Rare: Respiratory tract infections (excluding pneumonia), suicidal ideation, nervousness, muscle spasms, liver enzyme elevation, urticaria.
• The majority of these reactions are mild to moderate and typically subside with continued treatment.

Pregnancy & Lactation

• Pregnancy: Limited human data is available; however, animal studies indicate potential reproductive toxicity. Roflumilast is not recommended for use during pregnancy unless absolutely necessary, and effective contraception should be used by women of childbearing potential.
• Lactation: Roflumilast and its metabolites have been detected in animal milk, posing a possible risk to breastfeeding infants. It should therefore not be used during lactation.

Precautions & Warnings

• Not for acute relief: Milast-A is an anti-inflammatory agent and not a rescue medication for sudden bronchospasms.
• Weight monitoring: Patients taking Milast-A may experience weight loss, particularly during the first year of treatment. Underweight individuals should have regular weight assessments. If unexplained or concerning weight loss occurs, treatment discontinuation and further evaluation may be required.
• Pre-existing conditions: Due to limited clinical experience, Milast-A should not be initiated or continued in patients with severe immunological disorders (e.g., HIV, multiple sclerosis, lupus, progressive multifocal leukoencephalopathy), active serious infections, cancers (except basal cell carcinoma), or those on long-term immunosuppressive therapy.
• Cardiac health: Patients with NYHA Class 3 or 4 heart failure have not been studied and should not use Milast-A.
• Psychiatric risks: There is an increased risk of psychiatric side effects, including insomnia, anxiety, nervousness, depression, and rare instances of suicidal ideation or behavior. Caution is advised for patients with a history of psychiatric disorders. Any new or worsening psychiatric symptoms should be reported to a healthcare provider immediately, and discontinuation of Milast-A should be considered if suicidal tendencies emerge.
• Drug tolerance: Side effects such as diarrhea, nausea, abdominal pain, and headache usually diminish over time. However, patients with persistent intolerability should have their treatment reassessed.
• Theophylline: Concomitant use with theophylline for maintenance therapy is not supported by clinical data and is therefore not recommended.
• Lactose intolerance: Milast-A contains lactose and should not be taken by individuals with rare hereditary conditions like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Overdose Effects
Single doses of up to 5,000 micrograms (ten times the recommended dose) have been associated with symptoms such as headache, dizziness, gastrointestinal discomfort, palpitations, clamminess, and low blood pressure. In case of overdose, supportive medical care should be administered. As Milast-A is highly protein-bound, hemodialysis is unlikely to be effective in removing the drug from circulation. It is also unclear whether peritoneal dialysis would be effective.

Therapeutic Class
Antihistamines, anti-allergies, and hypo-sensitization agents.

Storage Conditions

• Store at temperatures below 30°C.
• Protect from light and moisture.
• Keep out of reach of children.