Buscopan

Manufacturer Boehringer Ingelheim

Distributor Metro Drug

Contents Hyoscine-N-butylbromide

Indications Acute GI, biliary & genitourinary spasm including biliary & renal colic. Parenterally also as an aid in diagnostic & therapeutic procedures eg gastroduodenal endoscopy, radiology.

Dosage Tab Adult & childn >6 yr 1-2 tab 3-5 times daily. Inj Acute attacks of colicky pain Adult & adolescent >12 yr 1-2 amp IV, IM or SC several times daily. Max: 100 mg daily. Infant & young childn Severe cases: 0.3-0.6 mg/kg body wt by slow IV, IM or SC several times daily. Max: 1.5 mg/kg body wt/day.

Administration May be taken with or without food.

Contraindications Tab: Myasthenia gravis & megacolon. Should not be used in patients who have prior sensitivity to hyoscine-N-butylbromide or any component of Buscopan. Inj: Untreated narrow-angle glaucoma, prostate hypertrophy w/ urinary retention, mechanical stenosis in the GIT, tachycardia, megacolon, myasthenia gravis. IM inj in patients on anticoagulants.

Special Precautions Avoid driving & operating machinery after parenteral administration.

Adverse Drug Reactions Xerostomia, tachycardia, urinary retention, allergic & skin reactions, rarely dyspnea (in patients w/ history of bronchial asthma or allergy). Inj: Visual accommodation disturbance, infrequently inj site pain (after IM inj), rarely anaphylactoid reactions & anaphylactic shock.

Drug Interactions Intensifies anticholinergic effects of TCAs, antihistamines, quinidine, amantadine, disopyramide & other anticholinergics (eg tiotropium, ipratropium). Enhanced tachycardiac effects of β-adrenergic agents. Dopamine antagonists reduce effects of both drugs on GIT.

Pregnancy Category (US FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

MIMS Class Antispasmodics

ATC Classification A03BB01 - butylscopolamine ; Belongs to the class of belladonna alkaloids, semisynthetic, quaternary ammonium compounds. Used in the treatment of functional gastrointestinal disorders.

Poison Schedule Tab:Non-Rx;Inj:Rx

Presentation/Packing

Form Photo Packing/Price

Buscopan inj 20 mg (amp) 10 × 1's (P1265.00/box)

Buscopan sugar-coated tab 10 mg

120's (P2383.00/pack)

Manufacturer: Boehringer Ingelheim

Distributor: Metro Drug

Isoket 5/Isoket 10/Isoket Retard 20/Isoket Retard 40

Manufacturer GlaxoSmithKline

Distributor Zuellig

Contents Isosorbide dinitrate

Indications Isoket 5/10 Treatment & prevention of angina pectoris attacks. Maintenance therapy after MI. Fresh MI w/ left ventricular failure. Acute left ventricular failure of other origins. Long-term treatment of chronic CHF. Chronic right ventricular failure, chronic cor pulmonale. Isoket Retard 20 Angina pectoris, prevention & subsequent treatment of MI. Isoket Retard 40 Long-term treatment of CHD. Long-term prevention of anginal attacks. Condition after MI. Chronic CHF, right heart failure & cor pulmonale.

Dosage Isoket 5/10 tab To control anginal attacks 1 tab sublingually. To prevent anginal attacks 3-4 tab daily. Isoket Retard 20/40 tab 1 tab bid.

Administration Should be taken on an empty stomach. Take on an empty stomach ½ hr before meals. Retard tab: Swallow whole, do not chew/crush.

Contraindications Hypersensitivity to isosorbide dinitrate, nitrates or nitrites. Low-filling pressure, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, cardiogenic shock, circulatory collapse, shock, aortic &/or mitral valve stenosis, severe hypotension, disease associated w/ an increased intracranial pressure, marked anemia, hypovolemia, closed-angle glaucoma. Concomitant use w/ phosphodiesterase inhibitors.

Special Precautions Hypothyroidism, hypothermia, malnutrition, severe liver or renal disease. Postural hypotension, syncope. Patients w/ disturbances of circulatory regulation, orthostatic hypotension, concomitant use w/ diuretics &/or w/ low systolic BP. Avoid using continuous & high dosage treatment. CAD leading to myocardial hypoxia. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Pregnancy & lactation.

Adverse Drug Reactions Headache. Dizziness, lightheadedness in upright position, drowsiness; reflex tachycardia; orthostatic hypotension; feeling of weakness.

Drug Interactions Sildenafil, tadalafil, vardenafil; antihypertensives; vasodilators, β-blockers, Ca antagonists, TCAs, antipsychotics, alcohol, dihydroergotamine.

Pregnancy Category (US FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

MIMS Class Anti-Anginal Drugs

ATC Classification C01DA08 - isosorbide dinitrate ; Belongs to the class of organic nitrate vasodilators. Used in the treatment of cardiac disease.

Poison Schedule Rx

Presentation/Packing

Form Packing/Price

Isoket Retard 40 MR tab 40 mg 50's (P947.60/pack)

Isoket Retard 20 SR tab 20 mg 50's (P677.60/pack)

Isoket 10 tab 10 mg 50's (P645.90/pack)

Isoket 5 tab 5 mg 50's (P517.90/pack)

Diatabs

Manufacturer United Lab

Distributor Biomedis

Contents Loperamide HCl

Indications Symptomatic control of acute & chronic diarrhea. Ileostomy.

Dosage Adult Acute diarrhea 2 cap followed by 1 cap after each unformed stool. Do not use for >5 days. Chronic diarrhea 2 cap then adjust dose until 1-2 solid stools/day are obtained. Max: 16 mg/day.

Administration May be taken with or without food.

Contraindications Constipation. Acute ulcerative colitis, pseudomembranous colitis, acute dysentery.

Special Precautions Hepatic dysfunction, persistent diarrhea, patients receiving anti-infectives. Pregnancy & lactation. Childn <12 yr.

Adverse Drug Reactions Constipation, nausea, vomiting, tiredness, drowsiness or dizziness, dry mouth.

Pregnancy Category (US FDA)

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1 sttrimester (and there is no evidence of a risk in later trimesters).

MIMS Class Antidiarrheals

ATC Classification A07DA03 - loperamide ; Belongs to the class of antipropulsives. Used in the treatment of diarrhea.

Poison Schedule Non-Rx

Presentation/Packing

Form Packing/Price

Diatabs cap 2 mg100's (P643.90/pack)500's (P3219.35/pack)8's (P54.00/blister)

Manufacturer: United Lab

Distributor: Biomedis

Dolfenal

Manufacturer Westmont

Distributor United Lab

Contents Mefenamic acid.

Indications Symptomatic relief of mild to moderately severe pain eg, headache, toothache, pain after minor surgery and tooth extraction, myalgia, dysmenorrhea and pain associated with cancer. Treatment of soft tissue rheumatism, sprain/tendonitis and low back pain.

Dosage Adults and Children >14 years: 250-500 mg every 8 hrs, as needed. Orally, preferably with food.Treatment with mefenamic acid should not be continued >7 days.For relief of dysmenorrhea, mefenamic acid should be initiated with the onset of bleeding and associated symptoms but for not more than 2-3 days.

Administration Should be taken with food. Take immediately after meals.

Contraindications Patients with known allergy to mefenamic acid, aspirin and other NSAIDs.

Warnings Risk of GI ulceration, bleeding and perforation in patients treated chronically with mefenamic acid.Liver and kidney functions should be monitored during long-term mefenamic acid intake.

Special Precautions Use with caution in patients with peptic ulcer, liver and kidney impairment, heart failure and high blood pressure. Effects on the Ability to Drive or Operate Machinery: Mefenamic acid may impair the ability to perform activities requiring mental alertness or physical coordination.Impairment of Fertility: Although there are no adequate and well-controlled studies to date in humans, mefenamic acid has been shown to have adverse effects in animals during reproduction studies.Use in pregnancy & lactation: Mefenamic acid should be used in pregnancy only when clearly needed.Mefenamic acid is distributed into milk and because of its potential for adverse effects on the cardiovascular system in infants, a decision should be made whether to discontinue nursing or discontinue medication with mefenamic acid.Use in children: Safety and efficacy of mefenamic acid in children <14 years have not been established.

Adverse Drug Reactions Gastrointestinal: Diarrhea, nausea, vomiting, abdominal pain, anorexia, heartburn, gastritis, flatulence, peptic ulcer.Hematologic: Occasionally, leucopenia, eosinophilia, thrombocytopenic purpura, agranulocytosis, pancytopenia and bone marrow hypoplasia. Mefenamic acid can inhibit platelet aggregation and may prolong bleeding time.Nervous System: Occasionally, drowsiness, nervousness, dizziness, fatigue, anxiety and insomnia.Ocular and Otic: Blurred vision, eye irritation and rarely, reversible loss of color vision.Renal Effects: Papillary necrosis and acute interstitial nephritis. Renal impairment accompanied by macular rash, hematuria, dysuria and mild elevations in BUN have also been reported.Hepatic Effects: Mild hepatotoxicity has been reported.Others: Urticaria, rash, facial edema, palpitation, dyspepsia and acute pancreatitis.

Drug Interactions Protein-Bound Drugs: Mefenamic acid could displace and be displaced from binding sites by anticoagulants, hydantoins, salicylates, sulfonamides and sulfonylureas causing either a decrease or an increase in mefenamic acid plasma levels.Anticoagulants and Thrombolytic Agents: Mefenamic acid may cause gastrointestinal (GI) bleeding, inhibit platelet aggregation and prolong bleeding time when taken concomitantly with anticoagulants.Lithium: Mefenamic acid reduces renal lithium clearance.Angiotensin-Converting Enzyme (ACE) Inhibitors: Concomitant use of drugs that inhibit prostaglandin synthesis, including mefenamic acid, may reduce the blood pressure response to ACE inhibitors.

Pregnancy Category (US FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

(in 3rd trimester or near delivery)

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Storage Store at temperatures not exceeding 30°C.

Mechanism of Action Nonsteroidal anti-inflammatory.Mechanism of Action: Mefenamic acid is a nonsteroidal anti-inflammatory drug (NSAID) which is an anthranilic acid derivative. It exhibits anti-inflammatory, analgesic and antipyretic activity by inhibiting prostaglandin synthesis in body tissues.Unlike most other NSAIDs, mefenamic acid appears to compete with prostaglandins for binding at the prostaglandin receptor site and thus, potentially affect prostaglandins that have already been formed.Pharmacokinetics: Mefenamic acid is rapidly absorbed after oral administration. Peak plasma concentrations occur about 2-4 hrs after ingestion. The plasma elimination half-life is approximately 2 hrs. Mefenamic acid is extensively bound to plasma proteins. Over 50% of a dose is excreted in the urine as unchanged drug or conjugates of mefenamic acid and its metabolites. Small amounts have been detected in breast milk.

MIMS Class Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

ATC Classification M01AG01 - mefenamic acid ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, fenamates.

Poison Schedule 250 mg:Non-Rx;500 mg:Rx

Presentation/Packing Tab 250 mg x 100's. 500 mg x 100's.

Biogesic

Manufacturer United Lab

Distributor Biomedis

Contents Paracetamol

Indications Relief of fever, minor aches & pains.

Dosage Tab Adult & childn >12 yr 1-2 tab 4-6 hrly as needed. Max: 8 tab in 24 hr. 250 mg/5 mL

susp Childn 7-12 yr 5-7.5 mL (1-1½ tsp), 3-6 yr 2.5-5 mL (½-1 tsp),1-2 yr 2.5 mL (½ tsp) 4 hrly. 120 mg/5 mL susp Childn 7-12 yr 10-15 mL (2-3 tsp), 3-6 yr 5-10 mL (1-2 tsp), 1-2 yr 5 mL (1 tsp) 4 hrly. Drops Childn 1-2 yr 1-1.2 mL, 7 mth to 1 yr 1 mL, 4-6 mth 0.6-1 mL, 0-3 mth 0.3-0.6 mL 4 hrly. Susp & Drops Max: 5 doses/24 hr.

Administration May be taken with or without food.

Contraindications Anemia, cardiac & pulmonary disease. Hepatic or severe renal disease.

Special Precautions Liver warning & disease. Other medicines containing paracetamol. Concomitant use of warfarin.

Adverse Drug Reactions

Allergic skin reactions & GI disturbances.

Drug Interactions Anticonvulsants, aspirin, INH, phenothiazines, alcohol.

Pregnancy Category (US FDA)

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).

MIMS Class Analgesics (Non-Opioid) & Antipyretics

ATC Classification N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

Poison Schedule Non-Rx

Presentation/Packing

Form Packing/Price

Biogesic oral drops 100 mg/mL (orange flavor) 15 mL x 1's (P50.25/bottle)

Biogesic oral susp 120 mg/5 mL(orange & strawberry flavor) 60 mL x 1's (P61.22/bottle)

Biogesic oral susp 250 mg/5 mL 60 mL x 1's (P87.28/bottle)

Biogesic tab 500 mg20's500's (P1429.08/pack)

Neozep/Neozep Forte/Neozep Non-Drowsy

Manufacturer United Lab

Distributor Myra

Contents Per 5 mL Neozep syr Phenylephrine HCl 2.5 mg, chlorphenamine maleate 0.5 mg, paracetamol 125 mg. Per mL Neozep oral drops Phenylephrine HCl 1 mg, chlorphenamine maleate 0.8 mg. Per Neozep Forte tab Phenylephrine HCl 10 mg, chlorphenamine maleate 2 mg, paracetamol 500 mg. Per Neozep Non-drowsy tab Phenylephrine HCl 10 mg, paracetamol 500 mg.

Indications Relief of runny nose, nasal congestion, post-nasal drip, itchy & watery eyes, fever, body pains & headache associated w/ common cold, flu, upper resp infections, allergic rhinitis & sinusitis.  Neozep Non-Drowsy Provides relief from symptoms of common cold, rhinitis & sinusitis w/o the sleepy feeling; for daytime use & when performing tasks that require mental alertness.

Dosage Neozep syr Childn >12 yr 15 mL (3 tsp), 7-12 yr 10 mL (2 tsp), 2-6 yr 5 mL (1 tsp). Neozep oral drops Childn 1-2 yr 1.5-2 mL, 6-12 mth 1.25-1.5 mL, 3-6 mth 1-1.25 mL, 1-3 mth 0.75-1 mL. All doses to be taken 6 hrly. Neozep Forte tab 1 tab. Neozep Non-Drowsy tab 1 tab 6 hrly.

Administration May be taken with or without food.

Contraindications Hyperthyroidism, HTN, coronary disease; CV disease, ventricular arrhythmia, acute-angle glaucoma, pheochromocytoma. MAOIs therapy; nephropathy.

Special Precautions Glaucoma, cardiac, renal or hepatic disease; diabetes, asthma; alcoholics. May impair ability to drive or operate machinery. Pregnancy.

Adverse Drug Reactions Neozep/Neozep Forte GI upsets, drowsiness, dizziness; dry mouth, difficulty in micturition, sweating, reduced appetite; epileptiform seizures (large doses).Neozep Non-Drowsy Nervousness, insomnia, dizziness, muscular weakness, headache, HTN. Rapid heart rate, tightness of chest, excitement & dilatation of pupils; skin rashes, itching, swelling of throat & rarely allergic reactions (large doses of paracetamol).

Drug Interactions Antihistamines may potentiate other CNS depressants. Possible additive effects w/ MAOIs, rauwolfia alkaloids, TCAs, ganglionic-blocking agents & halogenated hydrocarbon general anesth. Prolonged use of paracetamol may potentiate effects of oral anticoagulants. Phenothiazines.

MIMS Class Cough & Cold Preparations

ATC Classification R05DA20 - combinations ; Belongs to the class of opium alkaloids and derivatives. Used as cough suppressant.

Poison Schedule Non-Rx

Presentation/Packing

Form Packing/Price

Neozep oral drops 10 mL x 1's (P73.95/bottle)

Neozep syr 60 mL x 1's (P73.95/bottle)

Neozep Forte tab20's (P84.00/pack)500's (P2060.28/pack)

Neozep Non-Drowsy tab10's (P47.00/pack)100's (P453.56/pack)

Manufacturer: United LabDistributor: Myra

Zantac/Zantac 75

Manufacturer GlaxoSmithKline

Distributor Zuellig

Contents Ranitidine HCl

Indications Listed in Dosage.

Dosage Zantac tab Adult & adolescent ≥12 yr Duodenal & benign gastric ulcer Acute treatment: 150 mg bid or 300 mg once nightly for 4 wk. Duodenal ulcer in higher healing rates 300 mg bid for 4 wk. Long-term management: 150 mg once nightly. Smoking-associated duodenal ulcer relapse 300 mg once nightly. NSAID-associated peptic ulceration Acute treatment: 150 mg bid or 300 mg once nightly for 8-12 wk. Prophylaxis: 150 mg bid given concomitantly w/ NSAID therapy. Duodenal ulcer associated w/ H. pylori infection 300 mg once nightly or 150 mg bid w/ oral amoxicillin 750 mg tid & metronidazole 500 mg tid for 2-4 wk. Post-op ulcer 150 mg bid for 4 wk, continue further for 4 wk if not fully healed. GERD Acute treatment: 150 mg bid or 300 mg once nightly for 8-12 wk. Moderate to severe cases: 150 mg qid for up to 12 wk. Long-term management: 150 mg bid. Symptom relief: 150 mg bid for 2 wk, continue further for 2 wk if initial response is inadequate. Zollinger-Ellison syndromeInitially 150 mg tid, may be increased up to 6 g/day. Chronic episodic dyspepsia 150 mg bid for up to 6 wk. Prophylaxis of Mendelson's syndrome150 mg 2 hr prior to anesth & 150 mg the previous evening. Obstet patient in labor 150 mg 6 hrly. Prophylaxis of hemorrhage from stress ulceration in seriously ill patient or recurrent hemorrhage in patient bleeding from peptic ulceration 150 mg bid may be substituted for inj once oral feeding commences. Infant & childn 1 mth-11 yr Peptic ulcer Acute treatment: 4-8 mg/kg/day in 2 divided doses. Max: 300 mg/day. Duration: 4-8 wk. GERD 5-10 mg/kg/day in 2 divided doses. Max: 600 mg/day. Zantac

inj Adult Prophylaxis of Mendelson's syndrome 50 mg IM or slow IV inj 45-60 min prior to induction of general anesth. Prophylaxis of hemorrhage from stress ulceration in seriously ill patient or recurrent hemorrhage in patient bleeding from peptic ulceration 50 mg as slow (over 2 min) IV or IM 6-8 hrly or by intermittent IV infusion at 25 mg/hr for 2 hr, repeated 6-8 hrly. Prophylaxis of upper GI hemorrhage from stress ulceration in seriously ill patient 50 mg as slow IV followed by a continuous IV infusion of 0.125-0.25 mg/kg/hr. Childn May be given as slow IV inj over 2 min up to a max of 50 mg 6-8 hrly. Peptic ulcer (acute treatment) & GERD 2-4 mg/kg/day in 2-4 divided doses. Prophylaxis of stress ulceration in seriously ill patient 2-6 mg/kg/day in 2-4 divided doses.Zantac 75 tab Adult & childn ≥16

yr Treatment of presenting symptoms 1 or 2 tab up to 4 tab daily.

Administration May be taken with or without food. For prevention of symptoms associated w/ consuming food/drink, take ½-1 hr beforehand.

Contraindications Hypersensitivity.

Special Precautions History of acute porphyria. Renal & hepatic impairment. Pregnancy & lactation. Childn <16 yr. Elderly. Zantac tab/inj: Stop smoking. Exclude possibility of malignancy prior to therapy in patients w/ gastric ulcer, middle age & over w/ new or recently changed dyspeptic symptoms. Increased risk of developing community-acquired pneumonia in patients w/ chronic lung disease, diabetes & immunocompromised. Concomitant use w/ NSAIDs. Neonates <1 mth. Zantac inj: Rapid administration. Zantac 75: Unintended wt loss associated w/ dyspepsia. Stomach or duodenal peptic ulcer.

Adverse Drug Zantac 75: Sudden wheezing & chest pain or tightness; swelling of eyelids face, lips,

Reactions mouth or tongue; lumpy skin rash or hives, unexplained fever, faint feeling esp on standing.

Drug Interactions Altered prothrombin time w/ coumarin anticoagulants (eg warfarin). High doses may increase plasma levels of procainamide & N-acetylprocainamide. Increases (eg triazolam, midazolam, glipizide) or decreases (eg ketoconazole, atazanavir, delavirdine, gefitinib) absorption. Zantac tab: Reduced absorption w/ high doses (2 g) of sucralfate.

Pregnancy Category (US FDA)

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).

MIMS Class Antacids, Antireflux Agents & Antiulcerants

ATC Classification A02BA02 - ranitidine ; Belongs to the class of H2-receptor antagonists. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

Poison Schedule Zantac:Rx;Zantac 75:Non-Rx

Presentation/Packing

Form Photo Packing/Price

Zantac inj 50 mg/2 mL (amp) 5 × 1's (P930.60/box)

Zantac 75 tab 75 mg 48's (P784.60/pack)

Zantac tab 150 mg 60's (P2330.00/pack)

Zantac tab 300 mg 30's (P2324.50/pack)

Manufacturer: GlaxoSmithKline

Distributor: Zuellig

Ventolin

Manufacturer GlaxoSmithKline

Distributor Zuellig

Contents Salbutamol or as sulfate.

Indications Salbutamol is a selective β2-adrenoceptor agonist. At therapeutic doses, it acts on the β2-adrenoceptors of bronchial muscle with little or no action on the β1-adrenoceptors of the heart. With its fast onset of action, it is particularly suitable for the management and prevention of attack in mild asthma and for the treatment of acute exacerbations in moderate and severe asthma. The combination of salbutamol with guaifenesin is designed to relieve respiratory obstruction and improve pulmonary ventilation.Bronchodilators should not be the only or the main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations with limited physical capacity and PEF values <60% predicted at baseline with >30% variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled (eg, beclomethasone dipropionate >1 mg/day) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision. Respiratory disorders where bronchospasm and excessive secretion of tenacious mucus are complicating factors eg, bronchial asthma, chronic bronchitis and emphysema.With this primary background corticosteroid treatment, salbutamol provides essential rescue medication for a severe asthmatic in treating acute exacerbations. Failure to respond promptly or fully to such rescue medication, signals a need for urgent medical advice and treatment.Salbutamol provides short-acting (4 hrs) bronchodilation with fast onset (within 5 min) in reversible airway obstruction due to asthma, chronic bronchitis and emphysema. It is suitable for long-term use in the relief and prevention of asthmatic symptoms.Salbutamol should be used to relieve symptoms when they occur and to prevent them in those circumstances recognized by the patient to precipitate an asthmatic attack (eg, before exercise or unavoidable allergen exposure).Salbutamol is particularly valuable as rescue medication in mild, moderate or severe asthma, provided that reliance on it does not delay the introduction and use of regular inhaled corticosteroid therapy.Routine management of chronic bronchospasms, unresponsive to conventional therapy.Treatment of acute severe asthma (status asthmaticus).The management of uncomplicated premature labor during the 3rd trimester of pregnancy following the control of uterine contractions with parenteral salbutamol.

Dosage Salbutamol has a duration of action of 4-6 hrs in most patients. Increasing use of β2-agonists may be a sign of worsening asthma. Under these conditions, a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered.As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.Tablet: Adults: Usual Effective Dose: 2 tablets.If adequate bronchodilation is not obtained, each single-dose may be gradually increased to as much as 4 tablets.Some patients obtain adequate relief with 1 tablet.In the management of premature labor, after uterine contractions have been controlled by IV infusion of Ventolin and the infusion has been withdrawn, maintenance therapy can be continued with oral Ventolin. The usual dosage is 2 tablets.Children >12 years: 1-2 tablets; 6-12 years: 1 tablet; 2-6 years: ½-1 tablet.Elderly: In elderly patients or in those known to be unusually sensitive to β-adrenergic stimulant drugs, it is advisable to initiate treatment with 1 tablet.Syrup: Adults: 10 mL (salbutamol 4 mg). If adequate bronchodilation is not obtained, each single dose may be gradually increased to 20 mL (salbutamol 8 mg). Some patients obtain adequate relief with 5 mL of syrup (salbutamol 2 mg). Children >12 years: 5-10 mL, 6-12 years: 5 mL, 2-6 years: 2.5-5 mL.Elderly: In elderly patients or in those known to be unusually sensitive to β-adrenergic stimulant drugs, it is advisable to initiate treatment with 5 mL of syrup (salbutamol 2 mg).

All doses to be taken 3 or 4 times daily.Inhaler: Ventolin Inhaler is administered by the inhaled route only.As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased upon medical advice.In patients who find coordination of a pressurized metered-dose inhaler difficult, a spacer may be used with Ventolin Inhaler.Infants and young children using Ventolin Inhaler may benefit from the use of a pediatric spaces device with a face mask (eg, Babyhaler). (See Clinical Studies under Actions.)Relief of Acute Bronchospasm: Adults: 100 or 200 mcg. Children: 100 mcg, the dose may be increased to 200 mcg if required.Prevention of Allergen or Exercise-Induced Bronchospasm: Adults: 200 mcg before challenge. Children: 100 mcg before challenge or exertion. The dose may be increased to 200 mcg if required.Chronic Therapy: Adults and Children: Up to 200 mcg 4 times daily. On demand use of Ventolin Inhaler should not exceed 4 times daily. Reliance on such supplementary use or a sudden increase in the dose indicates deteriorating asthma (see Precautions).Nebules: Ventolin Nebules are intended to be used undiluted. However, if prolonged delivery time is desirable (>10 min), dilution using sterile normal saline as a diluent may be required.Ventolin Nebules are to be used with a nebulizer, under the direction of a physician.The nebulizing solution must not be injected or swallowed.Delivery of the aerosol may be by facemask, 'T'-piece or via an endotracheal tube. Intermittent positive pressure ventilation may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air.As many nebulizers operate on a continuous flow basis, it is likely that nebulized drug will be released in the local environment. Ventolin Nebules should therefore be administered in a well ventilated room, particularly in hospitals when several patients may be using nebulizers at the same time. Adults and Children: A suitable starting dose of salbutamol by wet inhalation is 2.5 mg. This may be increased to 5 mg. Treatment may be repeated 4 times daily. In adults, higher dosing up to 40 mg/day can be given under strict medical supervision in hospital for the treatment of severe airway obstruction.Infants <18 months: Clinical efficacy of Ventolin Nebules is uncertain in infants. As transient hypoxemia may occur, supplemental oxygen therapy should be considered.Rotacaps: Ventolin Rotacap capsules are for inhalation use only, using a Ventolin Rotahaler inhaler.Relief of Acute Bronchospasm: Adults: 200 or 400 mg. Children: 200 mcg.Prevention of Allergen- or Exercise-Induced Bronchospasm: Adults: 400 mcg before challenge or exertion. Children: 200 mcg. All doses to be taken 3 or 4 times daily.Chronic Therapy: Adults: 400 mcg 3 or 4 times daily. Children: 200 mcg 3 or 4 times daily.

Administration Should be taken on an empty stomach. Take 1 hr before or 2 hr after meals.

Overdosage The most common signs and symptoms of overdose with salbutamol are transient β-agonist pharmacologically-mediated events (see Precautions and Adverse Reactions).Hypokalemia may occur following overdosage with salbutamol. Serum potassium levels should be monitored.Nausea, vomiting and hyperglycemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy eg, cardioselective β-blocking agents in patients presenting with cardiac symptoms (eg, tachycardia, palpitations). Beta-blocking drugs should be used with caution in patients with a history of bronchospasm.

Contraindications Patients with a history of hypersensitivity to salbutamol or to any components of Ventolin tablet, syrup, inhaler, nebules and rotacaps. Although salbutamol IV and occasionally, salbutamol tablets are used in the management of premature labor, uncomplicated by conditions eg, placenta previa, ante-partum hemorrhage or toxemia of pregnancy, inhaled Ventolin preparations are not appropriate for managing premature labour. Salbutamol presentations should not be used for threatened abortion.

Special Precautions The management of asthma should normally follow a stepwise program and patient response should be monitored clinically and by lung function tests.Increasing use of short-acting inhaled β2-agonists to control symptoms indicates deterioration of asthma

control. Under these conditions, the patient's therapy plan should be re-assessed. Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted.Salbutamol should be administered cautiously to patients with thyrotoxicosis.Potentially serious hypokalemia may result from β2-agonist therapy mainly from parenteral and nebulized administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.In the event of a previously effective dose of inhaled salbutamol failing to give relief for at least 3 hrs, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken.Patient's inhaler technique should be checked to make sure that aerosol actuation is synchronized with inspiration of breath for optimum delivery of the drug to the lungs.As maternal pulmonary edema and myocardial ischemia has been reported during or following treatment of premature labor with β2-agonist, careful attention should be given to fluid balance and cardiorespiratory function, including ECG should be monitored. If signs of pulmonary edema or myocardial ischemia develop, discontinuation of treatment should be considered.Ventolin Nebules must only be used by inhalation, to be breathed in through the mouth and must not be injected or swallowed.Ventolin Nebules should be used with caution in patients known to have received large doses of other sympathomimetic drugs.Patients receiving treatment at home with Ventolin Nebules must be warned that if either the usual relief is diminished or the usual duration of action reduced, they should not increase the dose or its frequency of administration, but should seek medical advice. A small number of cases of acute-angle closure glaucoma have been reported in patients treated with a combination of nebulized Ventolin Nebules and ipratropium bromide. A combination of nebulized Ventolin Nebules with nebulized anticholinergics should therefore be used cautiously. Patients should receive adequate instructions on the correct administration and be warned not to let the solution or mist enter the eye.Potentially serious hypokalaemia may result from β2-agonist therapy mainly parenteral and nebulized administration.In common with other β-adrenoceptor agonists, Ventolin Nebules can induce reversible metabolic changes eg, increased blood sugar levels. The diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.Lactic acidosis has been reported very rarely in association with high therapeutic doses of IV and nebulized short-acting β-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Adverse Reactions). Increase in lactate levels may lead to dyspnea and compensantory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting β-agonist treatment. It is, therefore, recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.Use in pregnancy & lactation: Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking multiple medications during their pregnancies. Because no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2-3%, a relationship with salbutamol use cannot be established.As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.

Adverse Drug Reactions Adverse events are listed as follows by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10,000 and <1/1000) and very rare (<1/10,000), including isolated reports. Very common and common events were generally determined from clinical trial data. Rare and very rare events were generally determined

from spontaneous data.Immune System Disorders: Very Rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.Metabolism and Nutrition Disorders: Rare: Hypokalemia. Potentially serious hypokalemia may result from β2-agonist therapy. Very Rare: Lactic acidosis. Lactic acidosis has been reported very rarely in patients receiving IV and nebulized salbutamol therapy for the treatment of acute asthma exacerbation.Nervous System Disorders: Common: Tremor (very common in Ventolin syrup), headache (common in Ventolin tablet). Very Rare: Hyperactivity.Cardiac Disorders: Common: Tachycardia. Uncommon: Palpitations (very common in Ventolin tablet and common in Ventolin syrup). Very Rare: Cardiac arrhythmia including atrial fibrillation, supraventricular tachycardia and extrasystoles (rare in Ventolin tablet and syrup). Vascular Disorders: Rare: Peripheral vasodilatation.Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Paradoxical bronchospasm.As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator. Salbutamol inhaler should be discontinued immediately, the patient assessed and if necessary alternative therapy instituted.Gastrointestinal Disorders: Uncommon: Mouth and throat irritation.Musculoskeletal and Connective Tissue Disorders: Uncommon: Muscle cramps (common in Ventolin tablet and syrup). Very Rare: Feeling of muscle tension.A few patients experience a feeling of tension; this is also due to the effects on skeletal muscle and not to direct CNS stimulation.Occasionally, headaches have been reported.Peripheral vasodilation and a compensatory small increase in heart rate may occur in some patients. Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely.

Drug Interactions Salbutamol and nonselective β-blocking drugs eg, propranolol, should not usually be prescribed together.Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).

Pregnancy Category (US FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Caution For Usage Instructions for Use and Handling: Syrup: Dilution: May be diluted with purified water (50% v/v). The resulting mixture should be protected from light and used within 28 days.A 50% v/v dilution of Ventolin syrup has been shown to be adequately preserved against microbial contamination. However, to avoid the possibility of introducing excessive microbial contamination, the purified water used for dilution should be recently prepared or alternatively it should be boiled and cooled immediately before use.Admixture of Ventolin syrup with other liquid preparation is not recommended.Inhaler: Replace the mouthpiece cover firmly and snap it into position. As with most inhaled medications in aerosol canister, the therapeutic effect of this medication may decrease when the canister is cold.Testing the Inhaler: Before using for the first time, remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well and release 2 puffs into the air or if it has not been used for several days, shake it well and release 1 puff into the air to make sure that it works.Using the Inhaler: Remove the mouthpiece cover by gently squeezing the sides of the cover.Check inside and outside of the inhaler including the mouthpiece for the presence of loose objects.Shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.Hold the inhaler upright between fingers and thumb with the thumb on the base, below the mouthpiece.Breathe out as far as is comfortable and then place the mouthpiece in the mouth between the teeth and close the lips around it but do not bite it.Just after starting to breathe in through the mouth, press down on the top of the inhaler to release

salbutamol while still breathing in steadily and deeply.While holding breath, take the inhaler from the mouth and take a finger from the top of the inhaler. Continue holding breath for as long as is comfortable.If taking further puffs keep the inhaler upright and wait about half a minute before repeating steps 3-7.Replace the mouthpiece, cover by firmly pushing and snapping the cap into position.Important: Do not rush steps 5, 6 and 7. It is important to breathe in as slowly as possible just before operating the inhaler.Practice in front of a mirror for the first few times. If a 'mist' coming from the top of the inhaler or the sides of the mouth has been seen, the patient should start again from step 2.If the doctor has given the patient a different instruction for using the inhaler, follow it carefully. Inform the doctor of any difficulties.Cleaning: The inhaler should be cleaned at least once a week. Remove the metal canister from the plastic casing of the inhaler and remove the mouthpiece cover. Rinse the actuator thoroughly under warm running water. Dry the actuator thoroughly inside and out. Replace the metal canister and mouthpiece cover. Cover firmly and snap it into position. Do not put the metal canister into water.Nebules: Dilution: May be diluted with sterile normal saline. Any unused solution in the chamber of the nebulizer must be discarded.Rotacaps: Must only be inserted into Ventolin Rotahaler immediately prior to use.Failure to observe this instruction will affect the delivery of the drug.The canister should not be broken, punctured or burnt, even when apparently empty.

Storage Tablet: Store at temperatures not exceeding 30°C.Syrup and Nebules: Store at temperatures <30°C. Protect from light.Inhaler: Prior storing Ventolin Inhaler ensure to replace the mouthpiece cover firmly and snap it into position. The canister should not be broken, punctured or burnt, even when apparently empty.Store at temperatures not exceeding 30°C. Instructions for Disposal: Inhaler: Rotacaps: To keep the rotacaps in good condition, it is important that they are stored in a dry place and where they will not be exposed to extremes of temperature. Store below 30°C.

Description Inhaler: Ventolin Inhaler is a pressurized metered-dose inhaler which delivers 100 mcg salbutamol (as sulfate) per actuation, into the mouthpiece of a especially designed actuator. It also contains the CFC-free propellant HFA134a. Each canister contains at least 200 actuations.Nebule: Each nebules of solution for inhalation contains 2.5 mL of solution equivalent to salbutamol 2.5 mg.Rotacap: Each rotacap contains a mixture of microfine salbutamol sulfate 200 mg  and large particle lactose (which contains milk protein) in hard gelatin cartridges.

Mechanism of Action Pharmacology: Pharmacodynamics: Salbutamol is a selective β2-adrenoceptor agonist. At therapeutic doses, it acts on the β2-adrenoceptors of bronchial muscle, with little or no action on the β1-adrenoceptors of cardiac muscle.Pharmacokinetics: Absorption: After administration by the inhaled route, between 10-20% of the dose reaches the lower airways. The remainder is retained in the delivery system or is deposited in the oropharynx from where it is swallowed. The fraction deposited in the airways is absorbed into the pulmonary tissues and circulation but is not metabolized by the lungs.After oral administration, salbutamol is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine. The bioavailability of orally administered salbutamol is about 50%.Distribution: Salbutamol is bound to plasma proteins to the extent of 10%.Metabolism: On reaching the systemic circulation, salbutamol becomes accessible to hepatic metabolism and is excreted, primarily in the urine, as unchanged drug and as the phenolic sulfate.The swallowed portion of an inhaled dose is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism to the phenolic sulfate. Both unchanged drug and conjugate are excreted primarily in the urine.Elimination: Salbutamol administered IV has a t½ of 4-6 hrs and is cleared partly renally and partly by metabolism to the inactive 4'-O-sulfate (phenolic sulfate) which is also excreted primarily in the urine. The feces are a minor route of excretion. The majority of a dose of salbutamol given IV, orally or by inhalation is excreted within 72 hrs. Salbutamol is bound to plasma proteins to the extent of 10%.Clinical Studies: Inhaler: Special Patient Populations: Children <4 years: Pediatric clinical studies

conducted at the recommended dose (SB020001, SB030001, SB030002) in patients <4 years with bronchospasm associated with reversible obstructive airways disease, show that the Evohaler has a safety profile comparable to that in children ≥4 years, adolescents and adults.Toxicology: Preclinical Safety Data: In common with other potent selective β2-receptor agonists, salbutamol has been shown to be teratogenic in mice when given SC. In a reproductive study, 9.3% of fetuses are found to have cleft palate at 2.5 mg/kg, 4 times the maximum human oral dose. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50 mg/kg/day orally throughout pregnancy resulted in no significant fetal abnormalities. The only toxic effect was an increase in neonatal mortality at the highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed cranial malformations in 37% of fetuses at 50 mg/kg/day, 78 times the maximum human oral dose.

MIMS Class Antiasthmatic & COPD Preparations

ATC Classification R03AC02 - salbutamol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.

Poison Schedule Rx

Presentation/Packing Tab 2 mg (white, circular, flat-faced with beveled edges, engraved on one face with "GX/CN3") x 100's. Syrup 2 mg/5 mL (orange-colored, orange-flavored, sugar-free) x 60 mL. Metered-dose inhaler 100 mcg/inhalation x 200 doses. Nebules 2.5 mg/2.5 mL x 30's. Rotacap 200 mcg x 100's. Rotahaler 1's.

Manufacturer: GlaxoSmithKline

Distributor: Zuellig

Hemostan

Manufacturer Biomedis

Distributor United Lab

Contents Tranexamic acid

Indications Listed in Dosage.

Dosage Cap O & G Menorrhagia/menometrorrhagia 1-1.5 g (12-25 mg/kg body wt) 6-8 hr for 3-4 days. Inj General surgeries 0.5-1 g (10-15 mg/kg body wt) IV 8-12 hrly immediately after surgery. Orally, 1-1.5 g 6-8 hrly. Coronary artery bypass surgery 1 g IV bolus before surgery or 30 mg/kg in aspirin treated patients; 200 mg/hr infusion during surgery. Valvular heart surgery 100 mg/kg body wt IV before surgery. Correction of congenital heart disease in childn Initial bolus 15 mg/kg body wt IV before & after surgery. Thoracic aortic surgery 1 g IV before skin incision, 400 mg infusion during surgery & 500 mg in pump priming. Orthopedic surgery knee replacement/arthroplasty 10 mg/kg body wt IV before surgery repeat after 3 hr. Total hip replacement/arthroplastyInitial dose: 10 mg/kg body wt IV bolus repeat after 3 hr & 1 mg/kg/hr continuous infusion for 10 hr after surgery. Scoliosis surgery Initial dose: 10 mg/kg body wt & infusion of 1 mg/kg/hr. Medical Epistaxis in cases of recurrent bleeding 1 g 8 hrly for 7 days. GI hemorrhage 1 g IV 4 hrly for 3 days; 1.5 g orally 6 hrly for 4 days. Hereditary angioneurotic edema 1-1.5 g 8-12 hrly. Dental extraction w/ coagulopathies 10 mg/kg body wt IV before surgery; 25 mg/kg body wt 6-8 hr for 6-8 days after surgery, orally.

Administration May be taken with or without food.

Special Precautions Not advisable to use for prolonged periods in patients predisposed to thrombosis. Not recommended for prophylaxis during pregnancy & before delivery.

Adverse Drug Reactions GI disorders, nausea, vomiting, anorexia, headache may appear, impaired renal insufficiency, hypotension when IV inj is too rapid.

Drug Interactions Increased risk of clotting when used w/ estrogen-containing OC.

Pregnancy Category (US FDA)

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1 sttrimester (and there is no evidence of a risk in later trimesters).

MIMS Class Haemostatics

ATC Classification B02AA02 - tranexamic acid ; Belongs to the class of amino acid antifibrinolytics. Used in the treatment of hemorrhage.

Poison Schedule Rx

Presentation/Packing

Form Packing/Price

Hemostan cap 250 mg 100's (P1905.95/pack)

Hemostan cap 500 mg 100's (P2585.41/pack)

Hemostan inj 250 mg/2.5 mL 5 × 1's (P803.77/box)

Hemostan inj 500 mg/5 mL 5 × 1's (P960.33/box)

Sterizol

Manufacturer Vendiz

Distributor Metro Drug

Contents Silver sulfadiazine

Indications Prevention & treatment of wound sepsis w/ 2nd & 3rd degree burns; infected leg ulcers.

Dosage Burns Apply 2 mm once or bid. Leg ulcers Apply as often as necessary.

Contraindications Hypersensitivity to sulfonamides.

Special Precautions Hepatic or renal impairment.

Adverse Drug Reactions Skin rashes, leukopenia.

MIMS Class Topical Antibiotics

ATC Classification D06BA01 - silver sulfadiazine ; Belongs to the class of topical sulfonamides used in the treatment of dermatological diseases.

Poison Schedule Rx

Presentation/Packing

Form Photo Packing/Price

Sterizol cream 1%

15 g x 1's (P224.00/tube)500 g x 1's (P2128.00/tube)

Manufacturer: Vendiz

Distributor: Metro Drug

Bactroban Ointment

Manufacturer GlaxoSmithKline

Distributor Zuellig

Contents Mupirocin

Indications Primary skin infections eg impetigo, folliculitis, furunculosis & ecthyma. Secondary infections eg infected eczema, infected traumatic lesions including abrasions, insect bites, minor wounds & burns. Bacterial contamination prophylaxis.

Dosage Apply bid-tid for up to 10 days.

Contraindications Hypersensitivity.

Special Precautions Not suitable for ophth or intranasal use. Do not use at the site of central venous cannulation nor in conjunction w/ cannulae. Avoid contact w/ eyes. Discontinue use if sensitization reaction or severe local irritation occur. Overgrowth of nonsusceptible organism in prolonged use. Moderate to severe renal impairment.

Adverse Drug Reactions

Burning (localized to area of application).

MIMS Class Topical Antibiotics

ATC Classification D06AX09 - mupirocin ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases.

Poison Schedule Rx

Presentation/Packing

Form Photo Packing/Price

Bactroban Ointment 2 %

5 g x 1's (P279.10/tube)15 g x 1's (P579.20/tube)

Manufacturer: GlaxoSmithKline

Distributor: Zuellig