1 SEDATING ANTIHISTAMINES 1.1.

1 __________________________________________________________________________________________________

1. ANTIHISTAMINES
Notes Precautions: The antihistamines may enhance the sedative effect of CNS depressants including alcohol, barbiturates, hypnotics, sedatives and tranquilizers. Used with caution in glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyroloduodenal obstruction, or bladder neck obstruction, and seizure disorders. Contraindications: In patients with asthmatic attack, premature or full-term neonates, pregnant women, and nursing mothers. Warnings: Patients undergoing treatment with antihistamines should not take charge of vehicles, or machinery; and should abstain from alcohol. Drug Interactions: Azole Antifungals (fluconazole, itraconazole, ketoconazole, miconazole) Alcohol, CNS depressant, cimetidine, macrolide antibiotics, MAO Inhibitors, mibefradil, quinine, protease inhibitors (ritonavia, indinavir, saquinavir, nelfinavir), serotonin reuptake inhibitors (fluoxetine, fluvoxamine, nefazodone paroxetine, sertraline). _____________________________________________ Injection
ED

12 mg daily); 2-5 years: 1 mg every 4-6 hours (maximum, 4 mg daily). Injection: Adults: IM, IV, SC, 5-40 mg (IV injection should be made over a period of 1 minute). Children under 12 years: SC, 87.5 mcg (0.0875 mg) or 2.5 mg/m of body surface every 6 hours as needed. Adverse Reactions: Frequent drowsiness, dry mouth, dizziness and irritability occur. Precautions & Contraindications & Warnings & Drug Interactions: See notes on page 1. Storage: < 30 C; < 25 C, protect from light (Injection) Preparations: Syrup
ED 2

2 mg / 5 ml

ED

ED

CHLORLEATE SYRUP Tablets 4 mg

;Silom;60 ml@ 9.25. B.

ED
ED ED

CHLORPHENIRAMINE MALEATE @ 0.50 B.

; G.P.O.;

; IM, slowly IV, SC

1.1 ANTIHISTAMINES (PLAIN)

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10 mg/ml

ED

CHLORPHENIRAMINE MALEATE @ 4.- B.

ED

; G.P.O.;

1.1.1

SEDATING ANTIHISTAMINES

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_______

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DIPHENHYDRAMINE HCL CHLORPHENIRAMINE MALEATE

Indications: For allergic disorders; for active and Indications: Oral: For the symptomatic relief of allergic conditions including urticaria and angioedema, rhinitis, conjunctivitis and in pruritic skin disorders. Injection: As an adjunct in the emergency treatment of anaphylactic shock and other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicates. Pregnancy risk factor: C Lactation: N/A Usual Dose: Oral: Adults and children over 12 years: 2-4 mg every 4-6 hours (maximum, 24 mg daily). Children: 6-12 years: 2 mg every 4-6 hours (maximum, prophylactic treatment of motion sickness; as a nighttime sleep aid; for parkinsonism (including druginduced) in the elderly intolerant of more potent agents; for mild cases of parkinsonism in other age groups; and for parkinsonism in combination with centrally-acting anticholinergics. As nighttime sleep aid and as an antitussive. Pregnancy risk factor: B Lactation: Enters breast milk/contraindicated Usual Dose: Oral: For allergic conditions: Adults, 25-50 mg t.i.d.-q.i.d., preferably after each meal and at bedtime.

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NR NS NX HAD (High Alert Drugs)

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2 1.1.1 SEDATING ANTIHISTAMINES /1.1.2 NON SEDATING ANTIHISTAMINES __________________________________________________________________________________________________ Motion sickness: Adults, 25-50 mg every 4-6 hours, not to exceed 300 mg in 24 hours. The dose should be given 30 minutes before exposure to motion; subsequent dose may be given before meals and at bedtime for the duration of the exposure. Nighttime sleep aid: Adults, 50 mg at bedtime. Parkinsonian syndrome: 25-50 mg t.i.d.-q.i.d. at 4-6 hours intervals. Parenteral: Adults: 10-50 mg; 100 mg if required; maximum daily dosage is
2

Dosing interval in hepatic impairment: hange dosing interval to every 24 hours in patients with primary biliary cirrhosis. Adverse Reactions: > 10 %: CNS: Slight to moderate drowsiness. Respiratory: Thickening of bronchial secretions. 1 % to 10 %: CNS: Hadache, fatigue, nervousness, dizziness. GI: Appetite increase, weight gain, nausea, diarrhea, abdominal pain, xerostomia. Neuromuscular & skeletal: Arthralgia . Respiratory: Pharyngitis. < 1 %: Angioedema, blurred vision, bronchospasm, depression, edema, epstaxis, hepatitis, hypotension, insomnia, myalgia, palpitations, paradoxial excitement, paresthesia, photosensitivity, rash, sedation, tremor, urinary retention. Drug Interactions: CNS depressants, anticholinergics. Contraindications: During pregnancy. Storage: 15 25 C Preparations: Syrup
ED

400 mg.

Children: 5 mg/kg/day or 150 mg/m /day. Maximum daily dosage is 300 mg divided into 4 doses. Adverse GI: GU: Reactions: vomiting, CNS: sedation, dizziness, pain, insomnia, nervousness, euphoria, headache, confusion. nausea, diarrhea, dysuria, abdominal constipation, anorexia, increase appetite, weight gain. Urinary frequency, urinary retention Respiratory: Thickening of bronchial secretion, dry mouth nose and throat. Precautions & Contraindications & Warnings & Drug Interactions: See notes on page 1. Incidence of drowsiness high. Drug should not be used in premature and newborn infants. Drug should not be used with ototoxic antibiotics, as the ototoxicity may be masked. Storage: < 25 C Preparations: Capsules 25 mg
ED ED

,
ED

10 mg / 5 ml ATARAX HIZIN Tablets

ED ED ED

; UCB/Olic; 50 ml @ 40.- B.

ED

; Ranbaxy/Unichem; 60 ml @ 20.- B.

ED

BENADRYL

10 mg ; Pfizer/Zuellig; @ 2.05 B.

ED

ATARAX HIZIN 25 mg
ED

; UCB/Olic; @ 1.50 B.

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; Ranbaxy/Unichem; @ 1.50 B.

HYDROXYZINE HCL
Indications: For the symptomatic management of anxiety and tension associated with psychoneuroses; chronic urticaria or atopic or contact dermatoses, and in histmine-mediated pruritus, and as a sedative before and after general anesthesia. Pregnancy risk factor: C Lactation: enters breast milk/contraindicated Usual Dose: Children: Oral: 0.6 mg/kg/dose every 6 hours. Adults: Antiemetic; IM: 25 100 mg/dose every 4 6 hours as needed Anxiety: Oral: 25-100 mg 4 times/day; maximum dose : 600 mg/day. Preoperative sedation: Oral : 50-100 mg, IM: 25100 mg Management of pruritis : Oral : 25 mg 3-4 times/day.

ED

ED

ATARAX HIZIN
ED

; UCB/Olic; @ 4.- B.

; Ranbaxy/Unichem; @ 1.50 B.

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1.1.2

NON-SEDATING ANTIHISTAMINES

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CETIRIZINE DIHYDROCHLORIDE
Indications: Symptomatic treatment of seasonal rhin itis and conjunctivitis, perennial allergic rhinitis as well as pruritus and urticaria of allergic origin. Pregnancy risk factor: B Lactation: enters breast milk/not recommended

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3 NON-SEDATING ANTIHISTAMINES 1.1.2 __________________________________________________________________________________________________ Usual Dose: Adults and children 6 yrs and older: 5-10 mg (1 tab) daily. The drug should be taken with a little liquid during the evening meal. Adverse Reactions: Headache, sedation, dry mouth, fatigue and nausea. Contraindications: Hypersensitivity to hydroxyzine or cetirizine. Drug Interactions: See notes on page 1. Storage: 15 25 C Preparations: Tablets
ED

efficacy have not been established for children <12 years of age. Contraindication: Hypersensitivity to desloratadine, loratadine, or any component of the formulation Drug Interactions: Increased Effect/Toxicity: With concurrent use of desloratadine and erythromycin or ketoconazole, the Cmax and AUC of desloratadine and its metabolite are increased; however, no clinicallysignificant changes in the safety profile of desloratadine were observed in clinical studies. Storage: 15 25 C Preparations: Tablet 5 mg
NR NR NS

; film-coated. ED 10 mg ED ZYRTEC ; UBC/Olic; @ 14 - B. ED

ZERTINE
ED

; Farmaline; @ 1.- B.

Solution ED
1 mg/ml ZYRTEC ZENSIL
ED

AERIUS

; Schering-Plough /Zuellig; @ 31.- B.

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ED

; UCB/Olic; 75 ml @ 129.- B.

FEXOFENADINE HCL
Indications: Symptomatic relief of seasonal allergic rhinitis in adults and children over 12 years. Symptoms treated effectively include sneezing; rhinorrhea; itchy nose, palate and throat; itchy, watery and red eyes. Pregnancy risk factor: C Lactation: Excretion in breast milk unknown/ use caution (AAP rates compatible) Usual Dose: 60 mg twice daily. High fat food should not be co-administered. A dose of 60 mg once daily is recommended in patients with decreased renal function. Adverse Reactions: 1 % - 10 %: Viral infection (cold, flu) (2.5 %), nausea (1.6 %), dysmenorrhea (1.5 %), drowsiness (1.3 %), dyspepsia (1.3 %) fatigue (1.3 %). Precautions: Pregnancy category C. Fexofenadine HCl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Safety and effectiveness in children < 12 years have not been established. Contraindications: Patients with known hypersensitivity to fexofenadine; nursing mothers. Drug Interactions: See notes on page 1. Preparations: Tablets
NR NR NR

; Silom/Silom; 60 ml @ 17.50 B.

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DESLORATADINE
Indications: Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR);treatment of chronic idiopathic urticaria (CIU) Pregnancy risk factor: C Lactation: Enters breast milk / not recommended Usual Dose: Adults and children > 12 years: 5 mg once daily Dosage adjustment in renal /hepatic impairment: 5 mg ever other day Adverse Reactions: CNS : >10% Headache 1-10 % Fatigue, somnolence, dizziness Endocrine &metabolic: 1-10 % Dysmenorrhea GI: 1-10% Xerostomia, nausea,dyspepsia Neuromuscular & skeletal: 1-10 % Myalgia Respiratory: 1-10% Pharyngitis Postmarketing and /or case reports: Anaphylaxis, bilirubin increased, dyspnea, edema, hypersensitivity reactions, liver enzymes increased, pruritus, rash, tachycardia, urticaria. Precautions: Dose should be adjusted in patients with liver or renal impairment. Use with caution in patients known to be slow metabolizers of desloratadine (incidence of side effects may be increased) .Safety and

60 mg

TELFAST

; Aventis/Zuellig; @ 8.50. B. ; Sriprasit ;@ 4 .-B.

FENAFEX

NR

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NR NS NX HAD (High Alert Drugs)

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4 1.1.2 NON-SEDATIVE ANTIHISTAMINES / 1.2.1ANTIHISTAMINES AND DECONGESTANTS __________________________________________________________________________________________________

LEVOCETIRIZINE
Indications: Treatment of symptoms associated with allergic conditions such as: Seasonal allergic rhinitis (including ocular symptoms); Perennial allergic rhinitis; Chronic urticaria. Pregnancy risk factor: N/A Lactation: N/A Usual Dose: 5 mg once daily Dosage adjustment in renal impairment: : No dose adjustment is needed in patients with solely hepatic impairment .In patients impairment and renal impairment, adjustment of the dose is recommended . Adverse drug reaction: Mainly mild to moderate side effects such as dry mouth, headache, fatigue, somnolence, asthenia, rhinitis, pharyngitis, abdominal pain and migraine have been reported commonly (above 1%) Precautions: Not recommended in children aged less than 6 years since the currently available film-coated tablets do not yet allow dose adaptation .Precaution is recommended with intake of alcohol. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine . Contraindication: History of hypersensitivity to levocetirizine or any of the other constituents of the formulation or to any piperazine derivatives.Patients with severe renal impairment at less than 10 ml/min creatinine clearance. Drug Interaction: N/A Storage: 15 30 C Preparations: Tablet 5 mg
NR NR NS

Children 2-12 yrs: Body weight > 30 kg: 10 mg OD. Body weight < 30 kg: 5 mg OD. Adverse Reactions: > 10 %: CNS: Headache, somnolence, fatique. 1 % - 10 %: CVS: Hypotension, hypertension, palpitations, tachycardia CNS: Anxiety, depression. Endocrine& metabolism: Breast pain. Neuromuscular& skeletal: Hyperkinesia, arthragias. Respiratory: Nasal dryness, pharygitis, dyspnea. Miscellaneous: Diaphoresis. Precautions & Contraindications & Warnings & Drug Interactions: See notes on page 1. In Usual Dose, Loratadine seemed to cause a lower incidence of sedation/somnolence than traditional antihistamines, and it has little anticholinergic effects. Storage: < 25 C; 2 30 C (Clarityne) Preparations: Tablets
ED ED

10 mg

CLARITYNE @ 15.- B. LORITA Syrup

ED ED

ED

; Schering-Plough/Zuellig;

; Bangkokdrug/Farmaline; @ 1.50 B.

ED

1 mg/ml

ED

CLARITYNE

; Schering-Plough/Zuellig;

100 ml @ 171.- B. _____________________________________________

1.2 ANTIHISTAMINES COMBINATIONS

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1.2.1

XYZAL ; UCB / Olic ; @ 20.- B. _____________________________________________

ANTIHISTAMINES AND DECONGESTANTS

_____________________________________________ Notes SYMPATHOMIMETICS: (e.g., ephedrine, pseudoephedrine, phenylephrine). Precautions: Use with cautions in patients with hypertension, hyperthyroidism, diabetic mellitus, cardiovascular disease, increased intraocular pressure or prostatic hypertrophy, and in pregnancy. Contraindications: MAOI therapy; hypersensitivity or idiosyncrasy to sympathomimetics; severe hypertension and coronary artery disease; in nursing mothers.

LORATADINE
Indications: For symptomatic relief of seasonal allergic rhinitis, and for the management of chronic idiopathic urticaria. Pregnancy risk factor: B Lactation: Enters breast milk/ not recommended (AAP rates compatible) Usual Dose: Adults and children > 12 yrs: 10 mg once daily on an empty stomach.
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5 ANTIHISTAMINES AND DECONGESTANTS 1.2.1 __________________________________________________________________________________________________ Tablets

NR

BROMPHENIRAMINE + PHENYLEPHRINE
Indications: For the temporary relief of nasal and sinus congestion, sneezing, and rhinorrhea associated with the common cold and allergic rhinitis. Usual Dose: Children: 1/4 - 1 teaspoonful t.i.d.-q.i.d. according to age. Adults: 5-10 ml t.i.d.-q.i.d. (Dimetapp Elixer ). 1 tab. every 4-6 hours. (Denasal Tab). Pregnancy risk factor: C Adverse and page 4. Storage: 15 25 C Preparations: Elixir
NR NR

Triprolidine HCl 2.5 mg, Pseudoephedrine HCl 60 mg ACTIFED

NR

; Glaxo/Diethelm; @ 3.75 B. ; BM Pharmacy; @ 1.- B.

SULIDINE

NR

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LOLATADINE + PSEUDOEPHEDRINE SULFATE

Indications: Temporary relief of seasonal allergic

Reactions

&

Precautions

&

Contraindications & Warnings: See notes on page 1

rhinitis and nasal congestion Usual Dose: Adults and children over 12 years : 1 tablet every 12 hours. Adults and children over 12 years or wt. >30 kg 5 ml bid. Childn 6-12 yr. or wt < 30kg 2.5 ml bid.

DIMETAPP ELIXIR

(each 5 ml contains :-

Dosage adjustment in renal impairment : 1 tablet daily . Pregnancy risk factor: B Adverse and page 4 Reactions & Precautions & Contraindications & Warnings: See notes on page 1

Brompheniramine Maleate 2 mg, Phenylephrine HCl 5 mg); Whitehall/U.S.Summit; 60 ml @ 28.- B. Tablets

NR NR

DENASAL

(each tab contains: Brompheniramine

Storage: < 30 C Preparations: Syrup

NS

Maleate 4 mg, Phenylephrine HCl 10 mg); The Medic Pharm/MD Pharm Ltd; @ 1.50 B. _____________________________________________

Each 5 ml contains: Loratadine 5 mg, Pseudoephedrine HCl 60 mg CLARINASE SYRUP /Zuellig ; @ 262.- B.
NS

TRIPROLIDINE + PSEUDOEPHEDRINE
Indications: Acute rhinitis, sinus congestion & sinusitis, common cold, hay fever, flu. Usual Dose: Adults and children over 12 years: 1 tab t.i.d. Adults and children over 12 years: 2 teaspoonful t.i.d. Children: 6-12 years: 1 teaspoonful t.i.d.; 2-5 years: 1/2 teaspoonful t.i.d.; 6 months-under 2 years: 1/4

; Schering Plough

Tablets

NS

( Extended release )
NS

Loratadine 5 mg, Pseudoephedrine HCl 120 mg CLARINASE REPETAB /Zuellig ; @ 19.50. B. _____________________________________________ ; Schering Plough

teaspoonful t.i.d. Pregnancy risk factor: C Adverse 1 and page 4 Storage: < 30 C; protect from light Preparations: Syrup
NR

Reactions

&

Precautions

&

Contraindications & Warnings: See notes on page

Each 5 ml contains:- Triprolidine HCl 1.25 mg, Pseudoephedrine HCl 30 mg. SULIDINE ; B.M.Pharmacy; 2 oz @ 7.50 B.
NR

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ED