Indications Codeine

Dosage Adult : PO Pain 15-60 mg 4 hrly. Max: 360 mg/day. Cough suppressant 15-30 mg 3-4
times daily.Acute diarrhoea 15-60 mg 3-4 times daily. Syr 1-2 5 mL every 4-6
hr. IV/IM/SC Pain30-60 mg 4 hrly. Max: 240 mg/day.

Dosage Details Oral

Acute diarrhoea
Adult: 15-60 mg 3-4 times daily.

Oral
Mild to moderate pain
Adult: 15-60 mg 4 hrly. Max: 360 mg/day.
Child: ≤12 yr 0.5-1 mg/kg every 4-6 hr daily. Max: 240 mg daily.

Oral
Cough suppressant
Adult: 15-30 mg 3-4 times daily.
Child: 2-5 yr 3 mg; 6-12 yr 7.5-15 mg. Doses to be taken 3-4 times daily.

Parenteral
Mild to moderate pain
Adult: IV/IM/SC: 30-60 mg 4 hrly. Max: 240 mg/day.

Renal Impairment Dose adjustment may be needed.

Hepatic Impairment Dose adjustment may be needed.
Administration May be taken with or without food.
Contraindications Respiratory depression; obstructive airway disease; acute and severe asthma attack;
presence or suspicion of paralytic ileus, acute ulcerative colitis, antibiotic-associated colitis;
comatose patients; acute alcoholism. Patients w/ head injury, raised intracranial pressure.
Use in childn after tonsillectomy and/or adenoidectomy. Coadministration w/ MAO inhibitors
or w/in 2 wk of its discontinuation. Childn <1 yr.
Special Precautions Hypothyroidism, adrenocortical insufficiency; prostatic hyperplasia, hypotension, shock,
inflammatory or obstructive bowel disorders, myasthenia gravis. Patient who are ultra-rapid
metabolisers of codeine. Renal and hepatic impairment. Pregnancy and lactation. Elderly or
debilitated patients.
Adverse Drug Dependence, withdrawal symptoms; nausea, vomiting, constipation, drowsiness, confusion,
Reactions difficulty in micturition, ureteric or biliary spasms, urinary retention, dry mouth, dizziness,
sweating, facial flushing, headache, vertigo, bradycardia, tachycardia, palpitations, oedema,
postural hypotension, hypothermia, vertigo, restlessness, mood changes, decreased libido or
potency, hallucination, miosis, raised intracranial pressure, muscle rigidity, visual
disturbances.
Potentially Fatal: Respiratory depression and hypotension, w/ circulatory failure and
deepening coma (larger doses). Convulsions (especially in childn and infants).
Rhabdomyolysis.
Pregnancy Category
Parenteral/PO: C, D (if prolonged use/high doses at term)
(US FDA)
Patient Counselling May impair ability to drive or operate machinery.
Monitoring Monitor BP, heart rate, respiratory and mental status.
Parameters
Overdosage Symptoms: Somnolence, rash, miosis, vomiting, itching, ataxia, skin swelling, CNS
depression, respiratory depression, pinpoint-sized pupil. Management: Symptomatic and
supportive treatment including airway clearing and monitoring vital signs. Emptying the
stomach by aspiration or lavage. If ingestion of >350 mg by an adult or >5 mg/kg by a child
occur w/in an hour, consider activated charcoal. Administer naloxone in cases of coma or
respiratory depression, observe for at least 4 hr after ingestion.
Drug Interactions Enhanced depressant effects w/ anaesthetics, anxiolytics, hypnotics, TCAs, antipsychotics.
May alter effects of other compounds e.g. mexiletine, metoclopramide and domperidone.
Potentially Fatal: Additive effects w/ MAOI, avoid combination.

Food Interaction Additive depressant effects w/ alcohol. Avoid use w/ valerian, St John's wort, kava kava and
gotu kola as it may increase CNS depression.
Mechanism of Action Description: Codeine is a phenantrene-derivative opiate agonist which alters the perception
of and response to pain by binding to opiate receptors in the CNS, blocking the ascending
pain pathways. It also helps suppress cough by direct action in the medulla.
Onset: Oral: 0.5-1 hr.
Duration: 4-6 hr.
Pharmacokinetics:
Absorption: Adequate absorption in GI tract. Time to peak plasma concentration: 1-1.5 hr.
Distribution: Crosses placenta and enters breast milk. Plasma protein binding: Approx 7-
25%. Volume of distribution: Approx 3-6 L/kg.
Metabolism: Hepatic by O- and N-demethylation to morphine (active), norcodeine and other
metabolites including normorphine and hydrocodone.
Excretion: Via urine, mainly as conjugates w/ glucuronic acid. Plasma half-life: About 3-4 hr.

Storage Store between 15-30°C.

MIMS Class Cough & Cold Preparations / Analgesics (Opioid)

In treating diarrhoea, codeine works by acting on opioid receptors that

are found in the muscles lining the walls of the intestines. This reduces
the muscular contractions of the intestine (called peristalsis) that move
food and faecal matter through the gut. The speed at which the gut
contents are pushed through the intestines is therefore reduced, allowing
more time for water and electrolytes to be reabsorbed from the gut
contents back into the body. This results in firmer stools that are passed
less frequently.

ndications Loperamide
Dosage Adult : PO Acute diarrhoea Initial: 4 mg, then 2 mg after each loose stool. Max: 16
 mg/day. Chronic diarrhoea Initial: 4-8 mg/day in divided doses. Max: 16 mg/day.

Dosage Details Oral

Acute diarrhoea
Adult: Initially, 4 mg followed by 2 mg after each loose stool. Max: 16 mg daily. Discontinue if
clinical improvement is not observed w/in 48 hr.
Child: 4-8 yr 1 mg 3-4 times daily for up to 3 days; 9-12 yr 2 mg 4 times daily for up to 5
days.

Oral
Chronic diarrhoea
Adult: Initially, 4-8 mg daily in divided doses, adjusted if necessary. Max: 16 mg daily;
discontinue if no improvement at this dose after 10 days.
Administration May be taken with or without food.
Contraindications Conditions when inhibition of peristalsis is to be avoided; antibiotic-associated colitis, acute
ulcerative colitis, bacterial enterocolitis, acute inflammatory bowel disease, abdominal
distention.
Special Precautions Not intended for use as a primary treatment in acute dysentery. Hepatic impairment. Childn.
Pregnancy and lactation.
Adverse Drug Abdominal pain or bloating, nausea and vomiting, constipation, dry mouth, drowsiness,
Reactions dizziness, fatigue, epigastric pain, hypersensitivity reactions (e.g. rash).
Potentially Fatal: Paralytic ileus (particularly in infants and young childn).

Pregnancy Category ROUTE(S) : PO

(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).
Patient Counselling This drug may cause drowsiness or dizziness, if affected it may impair ability to drive or
operate machinery.
Monitoring
Monitor for signs of CNS toxicity (in patients w/ hepatic impairment).
Parameters
Overdosage Symptoms: CNS depression; constipation, urinary retention and ileus may occur.
Management: Employ gastric lavage followed by admin of activated charcoal. Naloxone HCl
may be given as antidote.
Drug Interactions Increased plasma levels w/ P-glycoprotein inhibitors (e.g. quinidine, ritonavir). May decrease
exposure to saquinavir.
Mechanism of Action Description: Loperamide reduces propulsive peristalsis and increases intestinal transit by
binding to the opiate receptor in the gut wall. It also increases the tone of the anal sphincter,
thereby reducing incontinence and urgency.
Pharmacokinetics:
Absorption: Approx 40% is absorbed from the GI tract. Time to peak plasma concentration:
2.5 hr (oral soln); 5 hr (cap).
Metabolism: Hepatically converted to desmethylloperamide via N-demethylation by CYP2C8
and CYP3A4 isoenzymes, CYP2B6 and CYP2D6 also play a role.
Excretion: Via faeces (as inactive conjugate); urine. Elimination half-life: Approx 10 hr.
Storage Store between 20-25°C.
MIMS Class Antidiarrheals
ATC Classification A07DA03 - loperamide ; Belongs to the class of antipropulsives. Used in the treatment of
diarrhea.

Manufacturer Sandoz
Contents Colloidal activated attapulgite
Indications Symptomatic treatment of nonspecific diarrhoea.
Dosage Adult 2 tab after initial bowel movement & 2 tab after subsequent bowel movement. Max daily dose: 12
tab. Childn 6-12 yr ½ adult dose. Max daily dose: 6 tab.

Administration May be taken with or without food.

Contraindications GIT stenotic lesions. Presence of high fever.
Special Precautions Therapy should not be exceeded >2 days or in the presence of fever. Childn <6 yr. Severe renal
insufficiency.
Drug Interactions May influence GI absorption of tetracyclines.
MIMS Class Antidiarrheals
ATC Classification A07BC04 - attapulgite ; Belongs to the class of other intestinal adsorbents.
Drug Classification B
Presentation/Packing
Form Packing/Price
25 × 4's (Rp103,000/boks)
Biodiar tab 630 mg
5 × 10's (Rp61,800/boks)

Indications Active charcoal

Dosage Adult : PO Acute oral poisoning 25-100 g as a single dose. GI disorders 0.975-3.9 g 3
times/day.
Dosage Details Oral
Acute oral poisoning
Adult: 25-100 g as a single dose. For multiple-dose treatment: 50-100 g as an initial dose
followed by not <12.5 g every hr. Alternatively, 25 mg every 2 hr or 50 mg every 4 hr.
Child: <1 yr: 1 g/kg/dose; 1-12 yr: 25-50 g/dose.

Oral
 Gastrointestinal disorders
Adult: 0.975 - 3.9 g tid.

Contraindications Cyanide, mineral acids, caustic alkalis, organic solvents, iron, ethanol, methanol poisoning;
lithium, methionine; intestinal obstruction, anatomically-broken GI tract, haemorrhage or GI
perforation. Concomitant use of charcoal with sorbitol: Patients with fructose intolerance;
Childn <1 yr.
Special Precautions Decreased peristalsis: administer within 1 hr of ingestion. Induce vomiting of ipecac syr
before admin of charcoal to prevent adsorption of ipecac. Petroleum distillate, caustic
ingestions may harm gastric lining upon induction of vomiting by charcoal. Limit admin of
charcoal in sorbitol doses to prevent loss of fluid and electrolyte. Monitor for active bowel
sounds before administering charcoal. Pregnancy.
Adverse Drug Vomiting, constipation, diarrhoea, black stools, swelling of abdomen, bowel obstruction;
Reactions platelet aggregation, charcoal embolism, thrombocytopenia, haemorrhage, hypoglycaemia,
hypocalcaemia, hypothermia, hypotension (haemoperfusion with activated charcoal);
blackening of teeth and mouth; hypernatraemia, hypokalaemia, hypermagnesemia (with
concomitant admin with cathartics).

Drug Interactions Reduces absorption of most drugs from GI tract. Decreases effectiveness of methionine via
adsorption. Decreases ipecac effect.

Food Interaction Milk products eg, milk, ice crm or sherbet, marmalade reduces charcoal effect. Food,
nutritional supplements or herbs must not be taken within two hr of ingestion of charcoal.
Mechanism of Action Description: Charcoal due to its large surface area, inhibits the GI absorption of toxic
substances or irritants eg, aromatic or benzenoid-type substances through adsorption. As a
laxative, the addition of sorbitol provides hyperosmotic environment thus causing catharsis.
Moreover, charcoal interferes with the enterohepatic circulation of bile acids resulting to a
lower cholesterol level.
Pharmacokinetics:
Absorption: Unabsorbed via the GI tract.
Metabolism: Unmetabolised.
Excretion: Via faeces (as unchanged form).

MIMS Class Antidotes & Detoxifying Agents

Manufacturer Sanbe
Contents Chlordiazepoxide 5 mg, clidinium Br 2.5 mg
Indications Autonomic & somatic symptoms because of anxiety. Symptomatic treatment of peptic ulcer,
hypersecretory & hypermotility of GIT, nervous dyspepsia, spastic & irritable colon, biliary, dyskinesia,
ureter spasm & ureter dyskinesia, irritable bowel syndrome, colitis, diarrhoea, dysmenorrhoea.
Dosage Adult 3-4 tab daily. Elderly & debilitated Initially 1-2 tab daily, increase gradually to the effective dose.

Administration Should be taken on an empty stomach: Take before meals & bedtime.
Contraindications Prostatic hypertrophy & glaucoma.
Special Precautions Hepatic disorder, long-term therapy. Pregnancy (1st trimester).
Adverse Drug Reactions Mental & visual disturbance, drowsiness, amnesia, dependence; urinary retention, hypotension.
 View ADR Monitoring Form
Drug Interactions Cimetidine; alcohol, other CNS depressants.
MIMS Class Antispasmodics
ATC Classification A03CA02 - clidinium and psycholeptics ; Belongs to the class of synthetic anticholinergic antispasmodics,
in combination with psycholeptics. Used in the treatment of functional gastrointestinal disorders.
Drug Classification G
Presentation/Packing
Form Packing/Price
Braxidin FC tab 10 × 10's (Rp80,000/boks)

Chlordiazepoxide hydrochloride and clidinium bromide (Librax) combines the anti-anxiety action
of chlordiazepoxide and the antispasmodic effects of clidinium. It also blocks the acid secretion
of the gastrointestinal tract and inhibits the action of nerves that are very active in certain
diseases. The FDA classifies the combination as possibly effective as additional therapy for
treatment of peptic ulcers, irritable bowel syndrome (IBS), GI spasms and some intestinal
infections.

ndications Listed in Dosage.

Dosage Adult : PO Heart failure; Supraventricular arrhythmias Rapid digitalisation: Loading dose:
0.75-1.5 mg in the 1st 24 hr. Slow digitilisation: 250 mcg 1-2 times/day. Uusal maintenance:
125-250 mcg/day.IV Emergency heart failure For patients who have not received cardiac
glycosides in the previous 2 wk: 0.5-1 mg via infusion as a single dose or in divided doses.
Maintenance: Usually via oral admin.
Dosage Details Intravenous
Emergency treatment in heart failure
Adult: For patients who have not received cardiac glycosides in the previous 2 wk. 0.5-1 mg
by IV infusion as a single dose over at least 2 hr or in divided doses with each dose given
over 10-20 minutes. Maintenance dose is usually given orally.

Oral
Heart failure, Supraventricular arrhythmias
Adult: Rapid digitalisation: Loading dose of 0.75-1.5 mg during the first 24-hr period as a
single dose or in divided doses every 6 hr for less urgent or greater risk cases. For mild heart
failure: Loading dose may not be required, 250 mcg 1-2 times daily. For patients with normal
renal function, steady-state plasma concentrations are usually achieved in about 7 days.
Usual maintenance: 125-250 mcg daily but may range from 62.5-500 mcg daily.
Child: Neonate <1.5 kg: Initial: 25 mcg/kg/day in 3 divided doses for 24 hr, then 4-6
mcg/kg/day in 1-2 divided doses; neonate 1.5-2.5 kg: Initial: 30 mcg/kg/day in 3 divided
doses for 24 hr, then 4-6 mcg/kg/day in 1-2 divided doses; Neonate >2.5 kg and child 1 mth-
2 yr: Initial: 45 mcg/kg/day in 3 divided doses for 24 hr, then 10 mcg/kg/day in 1-2 divided
doses. 2-5 yr: Initial: 35 mcg/kg/day in 3 divided doses for 24 hr, then 10 mcg/kg/day in 1-2
divided doses. 5-10 yr: Initial: 25 mcg/kg/day (max: 750 mcg/day) in 3 divided doses for 24
hr, then 6 mcg/kg/day (max: 250 mcg/day) in 1-2 divided doses. 10-18 yr: Initial: 0.75-1.5
mg/day in 3 divided doses for 24 hr, then 62.5-750 mcg/day in 1-2 divided doses. Reduce
doses if patient has been given cardiac glycoside in the preceding 2 wk.
Elderly: Lower doses are given.
Renal Impairment Dosage reductions may be needed.
Administration May be taken with or without food.
Reconstitution Intravenous:
Admin undiluted or diluted with a 4-fold or greater volume of sterile water for inj, NaCl 0.9%
inj, or dextrose 5% inj.
Incompatibility Using less than a 4-fold volume of diluent could lead to precipitation of the digoxin.
Contraindications Digitalis toxicity, ventricular tachycardia/fibrillation, obstructive cardiomyopathy. Arrhythmias
due to accessory pathways (e.g. Wolff-Parkinson-White syndrome).
Special Precautions Cardiac dysrhythmias, hypokalaemia, hypertension, IHD, hypercalcaemia,
hypomagnesaemia, electroconversion, chronic cor pulmonale, aortic valve disease, acute
myocarditis, congestive cardiomyopathies, constrictive pericarditis, heart block, elderly, renal
impairment, abnormalities in thyroid function; pregnancy. IV digoxin can only be given to
patients who have not received cardiac glycosides in the preceding 2 wk.
Adverse Drug Extra beats, anorexia, nausea and vomiting. Diarrhoea in elderly, confusion, dizziness,
Reactions drowsiness, restlessness, nervousness, agitation and amnesia, visual disturbances,
gynaecomastia, local irritation (IM/SC inj), rapid IV admin may lead to vasocostriction and
transient hypertension.
Potentially Fatal: Cardiac arrhythmias in combination with heart block.

Pregnancy Category ROUTE(S) : Parenteral/PO

(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.
Overdosage Symptoms: Hyperkalaemia, cardiac arrhythmias and heart block. Management: Treatment is
symptomatic and supportive. Reduce absorption by gastric lavage if present within 30 min of
ingestion. Do not induce vomiting or attempt passage of a gastric tube if presented >2 hr
after ingestion or already has toxic manifestations, as this may induce an acute vagal
episode and worsen digitalis-related arrhythmias. Activated charcoal is helpful in reducing
drug absorption. Monitor serum potassium levels and keep potassium levels between 4.0-5.5
mmol/l. Digoxin-specific antibody fragments (FAB) is a specific antidote for digoxin and may
be used to reverse potentially life-threatening ventricular arrhythmias due to digoxin
overdosage. Haemodialysis is unlikely to be useful.
Drug Interactions Effectiveness reduced by phenytoin, neomycin, sulphasalazine, kaolin, pectin, antacids and
in patients receiving radiotherapy. Metoclopramide may alter the absorption of solid dosage
forms of digoxin. Blood levels increased by calcium channel blockers, spironolactone,
quinidine and calcium salts.
Potentially Fatal: Electrolyte imbalances such as hypokalaemia and hypomagnesemia (e.g.
admin of potassium-losing diuretics, corticosteroids) can increase the risk of cardiac toxicity.
Food Interaction Absorption delayed.
Lab Interference May increase conc of urinary 17-hydroxycorticosteroids.
Mechanism of Action Description: Digoxin is a cardiac glycoside which has positive inotropic activity characterized
by an increase in the force of myocardial contraction. It also reduces the conductivity of the
heart through the atrioventricular (AV) node. Digoxin also exerts direct action on vascular
 smooth muscle and indirect effects mediated primarily by the autonomic nervous system and
an increase in vagal activity.
Pharmacokinetics:
Absorption: Absorption from the GI tract is variable.
Distribution: Widely distributed in tissues, including the heart, brain, erythrocytes, and
skeletal muscle. 20-30% bound to plasma proteins.
Excretion: Excreted mainly unchanged.

Storage Store at 25°C.

MIMS Class Cardiac Drugs

Laxadyn

Lactulax
Dulcolax