Drug information on Azelast (Azelastine) from Sun Pharmaceuticals Industries Ltd.

Medical Condition(s) for which Azelast may be prescribed

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•  Most Common: Bitter taste, headache, drowsiness, nasal burning, inflammation of pharynx/nose, dry mouth, sneezing, nausea, fatigue, dizziness, nosebleed and increased weight.

•  Body as Whole: Allergic reaction, back pain, viral infection, discomfort or uneasiness, pain in extremities, abdominal pain and fever.

•  Heart : Flushing, high blood pressure and fast heart rate.

•  Skin: Contact dermatitis, inflammation, hair follicle infection, skin infection and skin laceration.

•  Gastrointestinal: Constipation, inflammation of stomach/tongue/intestine, ulcer, vomiting, increased SGPT, diarrhea and toothache.

•  Metabolic: Increased appetite.

•  Musculoskeletal: Muscle/joint pain, jawbone dislocation and joint inflammation.

•  Central Nervous System: Hyperactivity and fainting.

•  Psychological: Anxiety, depersonalization, depression, nervousness, sleep disorder and abnormal thinking.

•  Respiratory: Asthma, coughing, throat burning, inflammation of larynx/bronchus/sinus, dry throat, shortness of breath, nasal congestion, nasal dryness and post nasal drip.

♦ •  Eye and ENT: Eye inflammation, eye pain, watery eyes, nasal sore and loss of taste.

•  Genitourinary : Presence of albumin in urine, breast pain, absence of menstrual period, blood in urine and increased urinary frequency.

Adult: The recommended dose is two sprays per nostril twice daily.
Child: The recommended dose is one spray per nostril twice daily.

It comes as a nasal spray.

Hypersensitivity.

• It may cause dizziness or drowsiness, do not drive a car or operate machinery while taking this medication.

• Avoid alcoholic beverages.

• Caution needed for pregnant and breastfeeding women.

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Avoid excess dosage.

Store it at controlled room temperature 20°- 25°C.

♦ Safety Labeling Changes Approved By FDA