Soniphen Capsule/Soniphen Injection

Soniphen Capsule/Soniphen Injection

diphenhydramine

Manufacturer:

Amherst Lab

Distributor:

Medichem

Marketer:

Amherst Parenterals
Concise Prescribing Info
Contents
Diphenhydramine HCl
Indications/Uses
Symptomatic relief of seasonal, perennial, vasomotor rhinitis; allergic conjunctivitis; mild, uncomplicated allergic skin manifestations of urticaria & angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; anaphylactic reactions adjunctive to epinephrine & other standard measures after acute manifestations have been controlled. Management of parkinsonism (including drug-induced) in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induced) in other age groups; in other cases of parkinsonism (including drug-induced) in combination w/ centrally acting anticholinergics. Short-term management of insomnia. Relief of cough caused by minor throat & bronchial irritation. Prevention & treatment of nausea, vomiting, &/or dizziness associated w/ motion sickness.
Dosage/Direction for Use
Cap Antihistamine 1 cap 6 hrly. Max: 300 mg/day. Antiparkinsonism 1 cap 6 hrly. Nighttime sleep aid 1 cap 20 min before going to bed. Antitussive 1 cap 8 hrly. Max: 300 mg/day. Motion sickness 1 cap 30 min before exposure to motion. Subsequent doses may be given 6 hrly & at bedtime for the duration of exposure. Max: 300 mg/day. IV/deep IM inj Do not exceed 25 mg/min IV rate. Adult 10-50 mg/dose, may be increased up to 100 mg. Max: 400 mg/day. Childn 5 mg/kg/day or 150 mg/m2/day 6 hrly in 4 divided doses daily. Max: 300 mg/day. Renal impairment Dosage intervals should be increased from 6-12 hr depending on the degree of renal impairment.
Administration
May be taken with or without food: May be taken w/ meals/milk. Subsequent doses for motion sickness may be taken before meals.
Contraindications
Hypersensitivity. Narrow angle glaucoma, asthma attack, prostatic hypertrophy, bladder-neck obstruction, porphyria; stenosing peptic ulcer & pyloroduodenal obstructions predisposing to increased risk of GI obstruction. Inj should not be used as a local anesth. Lactation. Premature infants & neonates.
Special Precautions
Liver disease (cirrhosis), glaucoma, urinary retention, myasthenia gravis, seizure disorders, hyperthyroidism, CV disease & HTN. Concomitant use w/ other antihistamines, sedatives or tranquilizers; alcohol; other diphenhydramine-containing products eg, topical formulations. Avoid use >7-10 nights. Insomnia persisting continuously for >2 wk. Local necrosis in SC or intradermal. May impair ability to drive or operate machinery. Not recommended during pregnancy. Childn. Elderly.
Adverse Reactions
Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose & throat; hypotension, headache, palpitations, tachycardia, extrasystoles; hemolytic anemia, thrombocytopenia, agranulocytosis; sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions; epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation; urinary frequency, difficult urination, urinary retention, early menses; thickening of bronchial secretions, tightness of chest & wheezing, nasal stuffiness. May interfere w/ wheal formation in skin testing for skin sensitizing reaginic antibodies.
Drug Interactions
Additive effects w/ alcohol & other CNS depressants eg, barbiturates, tranquilizers, hypnotics, sedatives, antianxiety agents & narcotic analgesics. Prolonged & intensified anticholinergic & CNS depressant effects w/ MAOIs eg, phenelzine, tranylcypromine, isocarboxazid, furazolidone, procarbazine. Potentiated anticholinergic side effects w/ anticholinergics eg, atropine. Increased plasma conc w/ β-blockers (metoprolol, carvedilol, labetalol, propranolol, timolol). Reduced absorption of antiTB agent [PAS (4-aminosalicylic acid)].
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AA02 - diphenhydramine ; Belongs to the class of aminoalkyl ethers used as systemic antihistamines.
Presentation/Packing
Form
Soniphen cap 50 mg
Packing/Price
30's (P15/cap)
Form
Soniphen inj 50 mg/mL
Packing/Price
1 mL x 10 × 1's (P143.25/inj)
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