Synactiv

Levocetirizine diHCl 5 mg, betamethasone Na phosphate 1 mg

Short-term treatment of urticaria & intermittent perennial or persistent allergic rhinitis.

Adult & adolescent ≥15 yr 1 tab once daily. Moderate renal impairment (CrCl 30-49 mL/min) 1 tab every 2 days.

Should be taken with food.

Hypersensitivity. Systemic infections. Severe renal (CrCl <10 mL/min) & hepatic impairment. Pregnancy & lactation.

Levocetirizine: May increase risk of urinary retention in patients w/ predisposing factors eg, spinal cord lesion, prostatic hyperplasia. May cause seizure aggravation in patients w/ epilepsy & at risk of convulsion. Pruritus may occur when treatment is stopped even if not present prior to treatment initiation. Wash-out period (3 days) is required prior to performing allergy skin tests. Concurrent intake of alcohol. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Betamethasone: May mask some signs of infection & new infections may appear during use. Prolonged use may produce posterior subcapsular cataracts (especially in childn), glaucoma w/ possible damage to optic nerves & may enhance secondary ocular infections due to fungi or viruses. Elevation of BP, salt & water retention & increased K excretion in ave & large doses. Increased Ca excretion. Drug-induced secondary adrenocortical insufficiency may result from too rapid w/drawal. Enhanced effect in patients w/ hypothyroidism or cirrhosis. Psychic derangements may appear & existing emotional instability or psychotic tendencies may be aggravated. Use in caution w/ ocular herpes simplex; nonspecific ulcerative colitis, probability of impending perforation, abscess or other pyogenic infection, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, HTN, osteoporosis & myasthenia gravis. May require dose adjustments w/ remission or exacerbation of disease process, patient's individual response to therapy & exposure to emotional or physical stress eg, serious infection, surgery or injury. Monitor patient for up to 1 yr following cessation of long-term or high-dose therapy. Restrict therapy in active TB to cases of fulminating or disseminated TB in which corticosteroid is used for management in conjunction w/ an appropriate anti-TB regimen. May produce false -ve results in nitroblue tetrazolium test. Do not vaccinate patients against smallpox & do not take other immunization procedures during therapy. Avoid exposure to chickenpox or measles in patients on immunosuppressant doses. Concurrently administer w/ salt &/or mineralocorticosteroid. May alter motility & number of spermatozoa. Renal impairment. Childn.

Levocetirizine: Headache, somnolence, dry mouth, fatigue. Betamethasone: Na retention, K loss, hypokalemic alkalosis, fluid retention, CHF, HTN; muscle weakness, corticosteroid myopathy, loss of muscle mass, aggravation of myasthenic symptoms in myasthenia gravis, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral & humeral heads, pathologic fracture of long bones, tendon rupture; peptic ulcer w/ possible subsequent perforation & hemorrhage, pancreatitis, abdominal distention, ulcerative esophagitis, hiccups; impaired wound healing, skin atrophy, thin fragile skin, petechiae & ecchymoses, facial erythema, increased sweating, suppressed reactions to skin tests, reactions (eg, allergic dermatitis, urticaria, angioneurotic edema); convulsions, increased ICP w/ papilledema (pseudotumor cerebri), vertigo, headache; menstrual irregularities, development of cushingoid state, suppression of fetal intrauterine or childhood growth, secondary adrenocortical & pituitary unresponsiveness, decreased carbohydrate tolerance, manifestations of latent DM, increased requirements of insulin or oral hypoglycemic agents; posterior subcapsular cataracts, increased IOP, glaucoma, exophthalmos; -ve nitrogen balance due to protein catabolism; euphoria, mood swings, severe depression to frank psychotic manifestations, personality changes, hyperirritability, insomnia; anaphylactoid or hypersensitivity & hypotensive or shock-like reactions.

Levocetirizine: Decreased cetirizine clearance w/ theophylline. Increased extent of exposure to cetirizine w/ ritonavir. Altered disposition of ritonavir w/ cetirizine. May cause additional reductions in alertness & impairment of performance w/ alcohol or other CNS depressants. Betamethasone: Metabolism may be enhanced & therapeutic effects be reduced w/ phenobarb, phenytoin, rifampin or ephedrine. Excessive corticosteroid effects w/ estrogen. May enhance hypokalemia w/ K-depleting diuretics. May enhance possibility of arrhythmias or digitalis toxicity associated w/ hypokalemia w/ cardiac glycosides. May enhance K depletion caused by amphotericin B. May increase or decrease anticoagulant effects of coumarin-type anticoagulants. May result in increased occurrence or increased severity of GI ulceration w/ NSAIDs or alcohol. May decrease blood salicylate conc. Concomitant use w/ ASA in hypoprothrombinemia. Adjust dose of concomitant antidiabetic drug. May inhibit response to somatotropin.

Antihistamines & Antiallergics

R06AE09 - levocetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.

Rx