Adair Tablet 500 mcg

Description

Indications
Adair is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

Use this medication only as directed by a registered physician.

Pharmacology
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential anti-inflammatory and anti-modulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.

Dosage & Administration
Adult dose: The recommended dose is one tablet of 500 micrograms Roflumilast once daily. Roflumilast may need to be taken for several weeks to achieve its effect. Roflumilast has been studied in clinical trials for up to one year.

Elderly (65 years and older): No dose adjustment is necessary.

Renal impairment: No dose adjustment is necessary.

Hepatic impairment: The clinical data with Roflumilast in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment, and therefore Roflumilast should be used with caution in these patients. Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Roflumilast.

Pediatric population: There is no relevant use of Roflumilast in the pediatric population (under 18 years). The tablet should be swallowed with water and taken at the same time every day. The tablet can be taken with or without food.

Use this medication only as directed by a registered physician.

Interaction
There are no proven cases of hazardous interactions. There is a case report of an interaction with ethanol and a compound containing pyrimethamine with dapsone and another of potentiation of betahistine with salbutamol. Betahistine is a histamine analogue, and concurrent administration of H1 antagonists may cause a mutual attenuation of effect of the active agents.

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

Side Effects
In clinical COPD studies, approximately 16% of patients experienced adverse reactions with Adair (compared to 5% in placebo). The most commonly reported adverse reactions were diarrhoea (5.9%), weight decrease (3.4%), nausea (2.9%), abdominal pain (1.9%), and headache (1.7%). The majority of these adverse reactions were mild or moderate. These adverse reactions mainly occurred within the first weeks of therapy and mostly resolved on continued treatment.

In the following data, adverse reactions are ranked under the MedDRA frequency classification:

• Common: Weight decreased, decreased appetite, insomnia, headache, diarrhoea, nausea, abdominal pain.
• Uncommon: Hypersensitivity, anxiety, tremor, vertigo, dizziness, palpitations, gastritis, vomiting, rash, muscle spasms, back pain, malaise, asthenia, fatigue.
• Rare: Suicidal ideation and behavior, depression, nervousness, dysgeusia, respiratory tract infections, haematochezia, gamma-GT increased, urticaria, myalgia, blood creatine phosphokinase (CPK) increased.

Pregnancy & Lactation
Pregnancy: There are limited data from the use of Roflumilast in pregnant women. Studies in animals have shown reproductive toxicity. Roflumilast is not recommended during pregnancy and in women of childbearing potential not using contraception. Roflumilast has been demonstrated to cross the placenta in pregnant rats.

Lactation: Available pharmacokinetic data in animals have shown excretion of Roflumilast or its metabolites in milk. A risk to the suckling child cannot be excluded. Roflumilast should not be used during breastfeeding.

Precautions & Warnings

• Adair is not indicated as a rescue medication for acute bronchospasms.
• Weight decrease: Patients should check their body weight regularly. If unexplained weight loss occurs, treatment should be stopped.
• Psychiatric disorders: Adair is associated with psychiatric risks such as insomnia, anxiety, nervousness, depression, and rare cases of suicidal ideation and behavior. Patients should notify their physician of any mood changes.
• Special conditions: Not recommended in patients with severe immunological diseases, acute infections, cancers (except basal cell carcinoma), or those on long-term immunosuppressive therapy. Patients with latent infections (e.g., tuberculosis, hepatitis, herpes) require close monitoring.
• Theophylline interaction: Concomitant treatment with theophylline is not recommended.
• Lactose intolerance: Patients with rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medication.

Overdose Effects
In Phase I studies, symptoms observed at an increased rate after single oral doses of 2,500 micrograms and one single dose of 5,000 micrograms (ten times the recommended dose) included headache, gastrointestinal disorders, dizziness, palpitations, light-headedness, clamminess, and arterial hypotension. In case of overdose, appropriate supportive medical care should be provided. Since Adair is highly protein-bound, haemodialysis is unlikely to be effective. It is not known whether Adair is dialyzable by peritoneal dialysis.

Therapeutic Class
Antihistamines, anti-allergies & hypo-sensitization.

Storage Conditions
Store below 30°C, away from light and moisture. Keep out of reach of children.

Use this medication only as directed by a registered physician.