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GELUMEN Suspension

SCHEDULING STATUS:

S2

PROPRIETARY NAME

(and dosage form):

GELUMEN Suspension

COMPOSITION:

Each 10 mL of suspension contains:

Dicyclomine hydrochloride 5 mg

Compressed aluminium hydroxide gel equivalent to dried aluminium hydroxide gel 400 mg

Light magnesium oxide 200 mg

PRESERVATIVES:

Nipastat 0,2% m/v

Chloroform 0,2% v/v

Benzyl alcohol 0,3% v/v

PHARMACOLOGICAL CLASSIFICATION:

A 11.4.2 Acid neutralisers with antispasmodics.

PHARMACOLOGICAL ACTION:

GELUMEN SUSPENSION has antacid properties.

INDICATIONS:

GELUMEN SUSPENSION is indicated as a antacid.

CONTRA-INDICATIONS:

Prostatic enlargement, paralytic ileus or pyloric stenosis where its use may lead to obstruction, severe ulcerative colitis, myasthenia gravis, glaucoma.

Patients with renal failure. Obstructive uropathy, thyrotoxicosis cardiac failure. Sensitivity to any of the ingredients.

WARNINGS:

GELUMEN SUSPENSION should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis and cardiac insufficiency or cardiac failure.

DOSAGE AND DIRECTIONS FOR USE:

Adults: Two to four medicine measures (10 – 20) mL three to four times daily.

Children over 2 years of age: One to two medicine measures (5 – 10) mL three to four times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

Side-effects that may occur because of the dicyclomine include dry mouth, blurred vision, flushing and dryness of skin, tachycardia with palpitations and arrhthmias, urinary retention and constipation. Its effect may be enhanced by other drugs with anticholinergic properties. Fatigue, sedation, rash, thirst, nausea and vomiting, headache and dizziness have been reported.

Preparations containing dicyclomine should be used with caution in elderly men. 5 – 10% of magnesium is absorbed, and retention in patients with impaired renal function may lead to neurological, neuromuscular and cardiovascular impairment. The urine of normal persons may become alkaline which decreases excretion of drugs that are weak bases. Magnesium may cause diarrhoea and mucosal irritation. Aluminium hydroxide absorbs phosphates and excessive doses of normal doses with a low phosphate diet may lead to phosphate depletion with renal rickets or osteomalacia. Use with care in patients with hiatal hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate the condition.

GELUMEN SUSPENSION may interfere with or reduce the absorption of anticholinergic medicines, barbiturates, digoxin, quinine, warfarin, tetracyclines and vitamins. The effects of dicyclomine hydrochloride may be enhanced by the concomitant administration of anticholinergic medicines such as antihistamines, amantadine, butyrophenones, phenothiazines and tricyclic antidepressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

Toxic doses of dicyclomine cause tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness, confusion and excitement, and hallucinations passing into delirium. A rash may appear on the face and upper trunk. In severe intoxication depression of the central nervous system may occur with hypertension or circulatory failure and respiratory depression. See further under “Side-Effects and Special Precautions”. Treatment is symptomatic and supportive.

IDENTIFICATION:

A white homogenous suspension with slight peppermint flavour.

PRESENTATION:

In bottles containing 200 mL, 350 mL and 2,5 litre.

STORAGE INSTRUCTIONS:

Store in a cool place, below 25°C.

KEEP OUT OF REACH OF CHILDREN.

MAYOGEL SUSPENSION

SCHEDULING STATUS:

Not Scheduled

PROPRIETARY NAME

(and dosage form):

MAYOGEL SUSPENSION

COMPOSITION:

Each 15 mL contains:

Aluminium hydroxide gel dried equivalent to

Aluminium oxide 282,00 mg

Magnesium trisilicate equivalent to

Magnesium oxide 120,00 mg

Alcohol 3,10% v/v

Preservatives:

Methylparaben 0,20% m/v

Propylparaben 0,02% m/v

PHARMACOLOGICAL CLASSIFICATION:

Category A11.4.1 Antacids – Acid neutralisers.

PHARMACOLOGICAL ACTION:

Antacid, with the capability to neutralise the acid in the stomach.

INDICATIONS:

For the relief of gastric acidity, dyspepsia and peptic ulcers.

CONTRA-INDICATIONS:

Hypersensitivity to any of the ingredients. In patients with impaired renal function. The safety of this medicine in pregnant women has not yet been established.

WARNINGS:

Do not take this product if you are presently taking a prescription antibiotic product containing any form of tetracycline. Do not use this product if you have kidney disease except under the advice and supervision of a doctor.

DOSAGE AND DIRECTIONS FOR USE:

Adults only.

Two to three medicine measures one to three hours after meals and at bedtime; according to the need of the patient.

Do not use the maximum daily dosage of this product for more than two weeks. except under the advice and supervision of a doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

Aluminium hydroxide may cause nausea, vomiting, and constipation. Large doses may cause intestinal obstruction. Excessive doses, or even normal doses in patients with low-phosphate diets, may lead to phosphate depletion accompanied by increased resorption and urinary excretion of calcium with the risk of osteomalacia. Osteomalacia, and also encephalopathy and dementia can occur in patients with chronic renal failure who receive relatively high doses of aluminium hydroxide as a phosphate-binding agent. Magnesium trisilicate may cause diarrhoea. If renal function is impaired hypermagnesaemia may result. The symptoms of which include flushing of the skin, thirst, hypotension due to peripheral vasodilation, drowsiness, confusion, loss of tendon reflexes due to neuromuscular blockade, muscle weakness, respiratory depression, cardiac arrhythmias, coma, and cardiac arrest.

Aluminium hydroxide and magnesium trisilicate may interfere with the absorption of other drugs when these are taken concomitantly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

Refer to ‘Side-Effects and Special Precautions’ above.

Treatment is symptomatic and supportive.

IDENTIFICATION:

White suspension with odour of peppermint.

PRESENTATION:

100 mL, 200 mL, 350 mL, 500 mL, and 2,5 L in bottles.

STORAGE INSTRUCTIONS:

Store in a cool place below 25°C in airtight containers.

KEEP OUT OF REACH OF CHILDREN.

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DRICLOR®DRICLOR®

BASED ON PATIENT INSTRUCTION LEAFLET:

SCHEDULING STATUS:
Unscheduled

PROPRIETARY NAME
(and dosage form):

DRICLOR®

COMPOSITION:
Driclor contains
Aluminium Chloride Hexahydrate USP 20% w/w (185 mg/mL) in alcohol.

PHARMACOLOGICAL CLASSIFICATION:
Antiperspirant

INDICATIONS:
Driclor is indicated for the treatment of excessive perspiration of the underarms, the hands and the feet.

CONTRA-INDICATIONS:
{not given}

DOSAGE AND DIRECTIONS FOR USE:
IMPORTANT:
Follow these instructions carefully. If there is anything you are not sure about, ask your doctor.

Instructions for use:
Before using DRICLOR

1. Ensure the affected areas are perfectly dry before applying DRICLOR. Do not apply to broken or irritated skin.
2. Do not bathe the affected areas just before using DRICLOR. Allow at least one hour after bathing.
3. Do not use a hair removal cream or shave the armpits 24 hours before or after using the product.

How and when to use DRICLOR

1. Apply last thing at night when completely relaxed.
2. Make sure the skin is perfectly dry before applying DRICLOR.
3. The next morning, wash and dry the areas you have treated. Do not re-apply DRICLOR again during the day.
4. At first, you should use DRICLOR each night until sweating stops during the day. You may then find you can cut down its use to twice weekly and then to once weekly and possibly even less often.
5. DRICLOR may cause temporary irritation or redness. If this troubles you, stop using DRICLOR for a while, and if necessary consult your doctor.


SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
DRICLOR is FOR EXTERNAL USE ONLY
Do not apply DRICLOR on or near eyes or mouth.
Avoid direct contact of DRICLOR with polished metal surfaces.
Avoid direct contact with clothing.
Plastic sheet may be used between the skin and nightclothes for added protection.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
{not given}

IDENTIFICATION:
Driclor is a clear colourless solution.

PRESENTATION:
Roll-on

STORAGE INSTRUCTIONS:
Always replace cap tightly after use.
Keep the bottle upright in a cool place below 25°.
DRICLOR is inflammable. Avoid a naked flame.
KEEP OUT OF REACH OF CHILDREN.

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ZEASORB Absorbent PowderZEASORB Absorbent Powder

BASED ON INFORMATION SUPPLIED ON THE CONTAINER

SCHEDULING STATUS:
Unscheduled

PROPRIETARY NAME
(and dosage form):

ZEASORB Absorbent Powder

COMPOSITION:

Chloroxylenol BPC 0,5% (5 mg/g)
Aluminium dihydroxyallantoinate 0,2% (2 mg/g)
Cellulose 46% (460 mg/g)

PHARMACOLOGICAL CLASSIFICATION:
{Dermatological preparation}

PHARMACOLOGICAL ACTION:
ZeaSORB helps absorb excess moisture in the groin, armpits and other skin-fold areas, and on the hands and feet.

INDICATIONS:
Excess moisture in the groin, armpits and other skin-fold areas, and on the hands and feet.

CONTRA-INDICATIONS:
{none stated}

DOSAGE AND DIRECTIONS FOR USE:
Dry the affected area, apply ZeaSORB and smooth over the surface of the skin, particularly between the joints and in folds.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Avoid inhalation of all powders.
Avoid contact with the eyes and with broken skin.

FOR EXTERNAL USE ONLY


KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
{none given}

IDENTIFICATION:

PRESENTATION:
50 g

STORAGE INSTRUCTIONS:
Store in a cool, dry place, below 30°C
Keep out of reach of children.

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MAYOGEL SUSPENSIONMAYOGEL SUSPENSION

SCHEDULING STATUS:
Not Scheduled

PROPRIETARY NAME
(and dosage form):

MAYOGEL SUSPENSION

COMPOSITION:
Each 15 mL contains:

Aluminium hydroxide gel dried equivalent to

Aluminium oxide 282,00 mg

Magnesium trisilicate equivalent to

Magnesium oxide 120,00 mg
Alcohol 3,10% v/v
Preservatives:
Methylparaben 0,20% m/v
Propylparaben 0,02% m/v


PHARMACOLOGICAL CLASSIFICATION:
Category A11.4.1 Antacids – Acid neutralisers.

PHARMACOLOGICAL ACTION:
Antacid, with the capability to neutralise the acid in the stomach.

INDICATIONS:
For the relief of gastric acidity, dyspepsia and peptic ulcers.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. In patients with impaired renal function. The safety of this medicine in pregnant women has not yet been established.

WARNINGS:
Do not take this product if you are presently taking a prescription antibiotic product containing any form of tetracycline. Do not use this product if you have kidney disease except under the advice and supervision of a doctor.

DOSAGE AND DIRECTIONS FOR USE:
Adults only.
Two to three medicine measures one to three hours after meals and at bedtime; according to the need of the patient.
Do not use the maximum daily dosage of this product for more than two weeks. except under the advice and supervision of a doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Aluminium hydroxide may cause nausea, vomiting, and constipation. Large doses may cause intestinal obstruction. Excessive doses, or even normal doses in patients with low-phosphate diets, may lead to phosphate depletion accompanied by increased resorption and urinary excretion of calcium with the risk of osteomalacia. Osteomalacia, and also encephalopathy and dementia can occur in patients with chronic renal failure who receive relatively high doses of aluminium hydroxide as a phosphate-binding agent. Magnesium trisilicate may cause diarrhoea. If renal function is impaired hypermagnesaemia may result. The symptoms of which include flushing of the skin, thirst, hypotension due to peripheral vasodilation, drowsiness, confusion, loss of tendon reflexes due to neuromuscular blockade, muscle weakness, respiratory depression, cardiac arrhythmias, coma, and cardiac arrest.
Aluminium hydroxide and magnesium trisilicate may interfere with the absorption of other drugs when these are taken concomitantly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Refer to ‘Side-Effects and Special Precautions’ above.
Treatment is symptomatic and supportive.

IDENTIFICATION:
White suspension with odour of peppermint.

PRESENTATION:
100 mL, 200 mL, 350 mL, 500 mL, and 2,5 L in bottles.

STORAGE INSTRUCTIONS:
Store in a cool place below 25°C in airtight containers.
KEEP OUT OF REACH OF CHILDREN.

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MERASYN GELMERASYN GEL

SCHEDULING STATUS:
NS

PROPRIETARY NAME
(and dosage form):

MERASYN GEL

COMPOSITION:
Each 5 mL:

Aluminium Hydroxide Dried Gel 200 mg
Magnesium Hydroxide 200 mg
Simethicone 20 mg
Methylcellulose 50 mg

Benzyl alcohol 0,3% v/v, Methylparaben 0,09% m/v, Propylparaben 0,012% m/v, Butylparaben 0,012% m/v (added as preservatives).

PHARMACOLOGICAL CLASSIFICATION:
A. 11.4 Antacids.

PHARMACOLOGICAL ACTION:
Both aluminium hydroxide and magnesium hydroxide reduce hyperacidity. Magnesium hydroxide has a rapid and aluminium hydroxide a prolonged antacid action. Peptic activity is inhibited through both antacids by causing elevation of the gastric pH. Aluminium hydroxide has a direct antipeptic action as well as a demulcent effect which helps protect the gastrointestinal mucosa and in this way prevents further irritation or erosion and so permits healing. Aluminium hydroxide has a mild constipating effect and magnesium hydroxide a mild laxative action; because of this balanced effect there is virtually no constipation or diarrhoea. Both antacids are non-systemic and there is virtually no risk of alkalosis developing.
Methycellulose has a demulcent action and helps protect gastrointestinal mucosa. Simethicone aids in the dispersion and inhibits formation of “mucus-surrounded” gas bubbles in the gastrointestinal tract. This anti-foam action is exerted by changing the surface tension of the gas bubbles so that they coalesce. This permits escape of trapped gas, which then can be eliminated through belching or though passing flatus via the rectum. Simethicone has been widely investigated and used. It has a rapid action and is non-toxic. Being physiologically inert, it has no effect on digestion and is not absorbed through the gastrointestinal mucosa. Infants have been shown to tolerate simethicone well.
By dispersing gas bubble with the anti-flatulent, contact with the gastric antacid is facilitated. Coverage of the mucosa by the antacid and demulcent agents is also improved.

INDICATIONS:
Gastric distress resulting from retention of gas and hyperacidity such as may occur in functional dyspepsia. The latter may result from dietary indiscretions, air swallowing, excessive smoking, constipation or altered gastric motor activity.
Gastric hyperactivity, gastritis (including iatrogenic gastritis), heartburn of pregnancy, oesophagitis.
Adjunctively, in peptic ulcer and hiatus hernia.

CONTRA-INDICATIONS:
Known idiosyncrasy to any of the ingredients.

DOSAGE AND DIRECTIONS FOR USE:
One to four medicine measuresful (5-20 mL) one to two hours after meals and at bedtime, or as frequently as the prescribing physician recommends. Shake well before use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Aluminium may cause nausea, vomiting and constipation. Large doses can cause intestinal obstruction. Excessive or normal doses in patients with low phosphate diets may cause phosphate depletion accompanied by increased resorption and urinary excretion of calcium with the risk of osteomalacia. Osteomalacia, with chronic renal failure on high aluminium dose as a phosphatebinding agent.
Magnesium may cause diarrhoea. Hypermagnesaemia may occur if renal function is impaired. Magnesium hydroxide and other magnesium salts, in the presence of renal insufficiency, may cause central nervous system depression.
Aluminium and magnesium may alter the absorption of other medicines from the gastro-intestinal tract if administered concomitantly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
There is no experience of overdosage with Merasyn Gel. Treatment is symptomatic and supportive.

IDENTIFICATION:
White viscous gel free from particles and lumps.

PRESENTATION:
200 mL and 350 mL amber glass bottles.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep out of reach of children.
Protect from light.

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CAVERJECT™ ۲۰ micrograms

SCHEDULING STATUS:

PROPRIETARY NAME

(and dosage form):

CAVERJECT™ ۲۰ micrograms

(Powder for injection)

COMPOSITION:

Each vial contains 20 micrograms alprostadil.

When reconstituted with 1 mL of the Bacteriostatic Water for Injection, each 1 mL contains: alprostadil 20 micrograms and benzyl alcohol 0,9% m/v as preservative.

PHARMACOLOGICAL CLASSIFICATION:

A 7.1 Vasodilators

PHARMACOLOGICAL ACTION:

Alprostadil (prostaglandin E1, PGE1) is one of a family of naturally-occurring acidic lipids, and is present in various mammalian tissues and fluids, including the semen of fertile men.

Alprostadil has a diverse pharmacologic profile, among which some of its more important effects are vasodilation, inhibition of platelet aggregation, inhibition of gastric secretion, and stimulation of intestinal and uterine smooth muscle.

The pharmacologic effect of alprostadil in the treatment of erectile dysfunction is presumed to be mediated by inhibition of alpha1-adrenergic activity in penile tissue and by its relaxing effect on cavernosal smooth muscle, thus, alprostadil induces erection by relaxation of the trabecular smooth muscle and by dilation of cavernosal arteries. This leads to expansion of the lacunar spaces and entrapment of blood by compressing venules against the tunica albuginea – a process referred to as the corporal veno-occlusive mechanism.

Alprostadil, when given by intracavernosal injection, induces an erection within 10 to 30 minutes after administration and the duration of erection is dose-dependant.

Pharmacokinetics:

Following intracavernosal injection of 20 micrograms of alprostadil, mean peripheral levels of alprostadil at 30 and 60 minutes after injection are not significantly greater than baseline levels of endogenous PGE1. Peripheral levels of the major circulating metabolite, 15-oxo-13,14-dihydro-PGE1, increase to reach a peak 30 minutes after injection and return to pre-dose levels by 60 minutes after injection. Any alprostadil entering the systemic circulation from the corpus cavernosum will be rapidly metabolised.

Following intravenous administration, approximately 80% of the circulating alprostadil is metabolised in one pass through the lungs, primarily by beta and omega-oxidation. The metabolites are excreted primarily by the kidney and excretion is essentially complete within 24 hours. There is no evidence of tissue retention of alprostadil or its metabolites following intravenous administration.

INDICATIONS:

Treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic or mixed aetiology.

An adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

CONTRA-INDICATIONS:

Intracavernosal alprostadil should not be used in patients who have a known hypersensitivity to alprostadil, benzyl alcohol, or any of the other constituents, or in patients who have conditions that might predispose them to priapism such as sickle cell anaemia or trait, multiple myeloma, or leukaemia, or in patients with anatomical deformity of the penis such as angulation, cavernosal fibrosis, or Peyronie’s disease. Patients with a penile implant should not be treated with CAVERJECT.

CAVERJECT should not be used in men in whom sexual activity is medically inadvisable or contra-indicated.

CAVERJECT should not be used in women or children and is not for use in newborns.

WARNINGS:

Prolonged erection and/or priapism may occur. Patients should be instructed to report to a physician any erection lasting for a prolonged time period, such as 4 hours or longer. Treatment of priapism should be according to established medical practice ( See KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT ).

Penile fibrosis, including angulation, fibrotic nodules and Peyronie’s disease occurred in 3% of patients in clinical studies with CAVERJECT. Regular follow-up of patients, with careful examination of the penis, is strongly recommended to detect signs of penile fibrosis. Treatment with CAVERJECT should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or Peyronie’s disease.

Patients on anticoagulants such as warfarin or heparin may have increased propensity for bleeding after the intracavernosal injection.

Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy with CAVERJECT.

Use of intracavernosal alprostadil offers no protection from the transmission of sexually transmitted diseases. Individuals who use alprostadil should be counselled about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV). The injection of CAVERJECT can induce a small amount of bleeding at the site of injection and in patients, infected with blood-born diseases, this could increase the transmission of such disease to the partner.

DOSAGE AND DIRECTIONS FOR USE:

Alprostadil is administered by direct intracavernosal injection. A 27-30 gauge needle is recommended.

The first injection of alprostadil must be done by medically trained personnel.

After proper training and instruction, alprostadil may be injected at home. If self-administration is planned, the physician should make an assessment of the patient’s skill and competence with the procedure. The intracavernosal injection must be done under clean conditions and the vial and injection site must be cleaned with the swabs provided. The site of injection is usually along the dorso-lateral aspect of the proximal third of the penis. Visible veins should be avoided.

The side of the penis that is injected and the site of the injection must be alternated.

The injection site must be compressed (using an alcohol swab to cover the injection site) until the bleeding has stopped.

The dose of CAVERJECT should be individualised for each patient by careful titration under supervision by a physician. The dose that is selected for self-injection treatment should provide the patient with an erection that is satisfactory for sexual intercourse. It is recommended that the dose administered produces a duration of erection not exceeding one hour. If the duration is longer, the dose should be reduced. The majority of patients achieve a satisfactory response with doses in the range of 10 to 20 micrograms. Doses greater than 60 micrograms of alprostadil are not recommended. While on self-injection, it is recommended that the patient visits the prescribing physician’s office every 3 months. At that time, the efficacy and safety of the therapy should be assessed and the dose of CAVERJECT should be adjusted if needed.

Reconstitution of injection:

Flip off the plastic cap from the vial, and use one of the swabs to wipe the rubber cap. Fit the 22 gauge needle to the pre-filled syringe. Inject the 1 mL of diluent into the vial, and shake to dissolve the powder entirely. Withdraw slightly more than the required dose of CAVERJECT solution, remove the 22 gauge needle, and fit the 27 gauge needle. Adjust volume to the required dose for injection.

Following administration, any unused contents of the vial or syringe should be discarded.

As an aid to aetiologic diagnosis:

Subjects without evidence of neurological dysfunction: 20 micrograms alprostadil to be injected into the corpus cavernosum and massaged through the penis. Should an ensuing erection persist for more than one hour detumescent therapy (see KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT) should be employed to prevent a risk of priapism prior to the subject leaving the clinic. Over 80% of subjects may be expected to respond to a single 20 microgram dose of alprostadil. At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state.

Subjects with evidence of neurological dysfunction: These patients can be expected to respond to lower doses of alprostadil. In subjects with erectile dysfunction caused by neurologic disease/trauma the dose for diagnostic testing must not exceed 10 micrograms and an initial dose of 5 micrograms is likely to be appropriate. Should an ensuing erection persist for more than one hour detumescent therapy (see KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT) should be employed to prevent a risk of priapism prior to the subject leaving the clinic. At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state.

Treatment:

Erectile dysfunction of vasculogenic, psychogenic or mixed aetiology:

The initial dose of alprostadil is 2,5 micrograms. The second dose should be 5 micrograms if there is a partial response, and 7,5 micrograms if there is no response. Subsequent incremental increases of 5-10 micrograms should be given until an optimal dose is achieved. If there is no response to the administered dose, then the next higher dose may be given within 1 hour. The patient must stay in the physician’s office until complete detumescence occurs. If there is a response, then there should be at least a 1-day interval before the next dose is given.

Erectile dysfunction of pure neurogenic (spinal cord injury) aetiology:

Dose titration should be initiated at 1,25 micrograms. The dose may be increased by 1,25 micrograms to a dose of 2,5 micrograms, followed by an increment of 2,5 micrograms to a dose of 5 micrograms, and then in 5 microgram increments until the dose that produces an erection suitable for intercourse and not exceeding a duration of 60 minutes. If there is no response to the administered dose, then the next higher dose may be given within 1 hour. The patient must stay in the physician’s office until complete detumescence occurs. If there is a response, then there should be at least a 1-day interval before the next dose is given.

The usual maximum recommended frequency of injection is no more than once daily and no more than three times weekly.

Reconstitution and storage:

Only the supplied diluent should be used to prepare solutions.

Reconstituted solutions are physically and chemically stable for a period of 24 hours at room temperature and for 7 days in the fridge if stored in the original container. Do not store the unused pack or reconstituted solution in a freezer.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

The most frequent adverse reaction after intracavernosal injection of CAVERJECT is penile pain. In studies, 34% of the patients reported penile pain at least once; however, this event was associated with only 11% of the administered injections. In the majority of the cases, penile pain was rated mild or moderate in intensity. 3% of patients discontinued treatment because of penile pain.

Painful erection is more likely to occur in patients with anatomical deformities of the penis, such as angulation, phimosis, cavernosal fibrosis, Peyronie’s disease or plaques.

Haematoma at the site of injection, which is related to the injection technique rather than to the effects of alprostadil, occurs less frequently (3%).

In a small number of patients prolonged erection (defined as an erection which lasts 4-6 hours) and/or priapism (defined as an erection which lasts 6 hours or longer) may occur. In the majority of cases, spontaneous detumescence occurred.

The following local adverse reactions occurred in a small number of patients: injection site ecchymosis, penile rash, penile oedema, and penile fibrosis. The following local adverse reactions were reported by fewer than 1% of patients: balanitis, injection site haemorrhage, injection site inflammation, injection site itching, injection site swelling, urethral bleeding, and penile warmth, numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, painful erection, and abnormal ejaculation.

In terms of systemic events, the following were reported for fewer than 1% of patients in clinical studies, and were judged to be possibly related to CAVERJECT use: testicular pain, testicular swelling, scrotal erythema, pain or tightness, urinary frequency, urinary urgency, impaired urination, hypotension, vasodilatation, hypertension, supraventricular extrasystole, peripheral vascular disorder, dizziness, hypaesthesia, buttock weakness, localized pain (buttocks pain, leg pain, genital pain, abdominal pain), headache, pelvic pain, back pain, flu syndrome.

Haemodynamic changes, manifested as decreases in blood pressure and increases in pulse rate, were observed during clinical studies, principally at doses above 20 micrograms and above 30 micrograms of CAVERJECT, respectively, and appeared to be dose-dependent. However, these changes were usually clinically unimportant; only 3 patients (0,2%) discontinued the treatment because of symptomatic hypotension.

CAVERJECT had no clinically important effect on serum or urine laboratory tests.

Interactions: None known. Not intended for co-administration with any other agent for the treatment of erectile dysfunction.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

The pharmacotoxic signs of alprostadil are similar in all animal species and include depression, soft stools or diarrhoea and rapid breathing. In animals, the lowest acute LD50 was 12 mg/kg which is 12,000 times greater than the maximum recommended human dose of 60 micrograms.

In man, prolonged erection and/or priapism are known to occur following intracavernosal administration of vasoactive substances, including alprostadil. Patients should be instructed to report to a physician any erection lasting for a prolonged time period, such as 4 hours or longer.

Treatment should be according to established medical practice.

The treatment of priapism (prolonged erection) should not be delayed more than 6 hours. Initial therapy should be by penile aspiration. Using aseptic technique, insert a 19-21 gauge butterfly needle into the corpus cavernosum and aspirate 20-50 mL of blood. This may detumesce the penis. If necessary, the procedure may be repeated on the opposite side of the penis. If still unsuccessful, intracavernosal injection of alpha-adrenergic medication is recommended. Although the usual contra-indication to intrapenile administration of a vasoconstrictor does not apply in the treatment of priapism, caution is advised when this option is exercised. Blood pressure and pulse should be continuously monitored during the procedure. Extreme caution is required in patients with coronary heart disease, uncontrolled hypertension, cerebral ischaemia, and in subjects taking monoamine oxidase inhibitors.

In the latter case, facilities should be available to manage a hypertensive crisis. A 200 microgram/mL solution of phenylephrine should be prepared, and 0,5 to 1,0 mL of the solution injected every 5 to 10 minutes. Alternatively, a 20 microgram/mL solution of epinephrine should be used. If necessary, this may be followed by further aspiration of blood through the same butterfly needle. The maximum dose of phenylephrine should be 1 mg, or epinephrine 100 micrograms (5 mL of the solution). As an alternative metaraminol may be used, but it should be noted that fatal hypertensive crises have been reported. If this still fails to resolve the priapism, urgent surgical referral for further management, which may include a shunt procedure, is required.

IDENTIFICATION:

CAVERJECT 20 micrograms Powder for injection: A white to off-white lyophilised powder

BACTERIOSTATIC WATER FOR INJECTION: Clear, colourless liquid, free of particles.

The reconstituted product is a clear, colourless solution.

PRESENTATION:

The following components are included in the pack:

CAVERJECT 20 micrograms Powder for injection: A single dose vial containing a white to off-white lyophilised powder.

BACTERIOSTATIC WATER FOR INJECTION: A pre-filled syringe containing the diluent solution which is 1 mL Bacteriostatic Water for Injections and benzyl alcohol 0,9% w/v; 2 syringe needles and 2 swabs.

 

 

  • توسط admin در دی ۱۱, ۱۳۴۸
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ALZAM 0,25 mg (tablet)

ALZAM 0,5 mg (tablet)

ALZAM 1,0 mg (tablet)

SCHEDULING STATUS:

S5

PROPRIETARY NAME

(and dosage form):

ALZAM 0,25 mg (tablet)

ALZAM 0,5 mg (tablet)

ALZAM 1,0 mg (tablet)

COMPOSITION:

Each tablet contains 0,25 mg, 0,5 mg or 1,0 mg alprazolam.

PHARMACOLOGICAL CLASSIFICATION:

A: 2.6 Tranquillisers.

PHARMACOLOGICAL ACTION:

Alzam (alprazolam) is an anxiolytic agent of the benzodiazepine group. Following oral administration, alprazolam is readily absorbed. Peak concentrations in plasma occur in one to two hours following administration. Plasma levels are proportionate to the dose given; over the dose range of 0,5 mg to 3,0 mg, peak levels of 8,0 to 37 ng/mL were observed. The mean half-life of alprazolam is 12-15 hours. Alprazolam and its metabolites are excreted primarily in the urine. The predominant metabolites are alpha-hydroxy-alprazolam and a benzophenone derived from alprazolam. In vitro, alprazolam is bound 70-80% to human serum protein.

INDICATIONS:

Alzam (alprazolam) is indicated for the treatment of anxiety disorders, or the short-term relief of symptoms of anxiety. Anxiety associated with depression is responsive to Alzam. Alzam is also indicated for the treatment of panic disorders for up to eight months. The doctor should periodically re-assess the usefulness of Alzam (alprazolam) in the treatment of anxiety disorders; anxiety associated with depression, for long term use exceeding six months has not been established.

Alzam is only indicated when the disorder is severe, disabling or subjecting the individuals to extreme stress.

CONTRA-INDICATIONS:

The safety of Alzam (alprazolam) in pregnancy has not been established. Alzam should not be administered during pregnancy. Do not administer during labour. Given during labour it crosses the placenta and may cause the floppy-infant syndrome characterised by central respiratory depression, hypothermia and poor sucking.

Alzam (alprazolam) should not be administered to nursing mothers, since alprazolam is excreted in human breast milk.

Alzam (alprazolam) is contraindicated in patients with known sensitivity to the benzodiazepines.

Alzam (alprazolam) is not recommended for use in patients whose primary diagnosis is schizophrenia.

Psychotic patients and patients suffering from mental depression or suicidal tendencies, unless there is a marked component of anxiety in their illness.

WARNINGS:

There is a potential for abuse and dependence. Withdrawal symptoms may occur after periods of ordinary therapeutic doses. Individuals who are prone to abuse medicines, such as alcoholics and drugs addicts or patients on other CNS depressants, should be under careful surveillance while receiving a benzodiazepine because of the predisposition of such patients to habituation and dependence.

Patients receiving Alzam (alprazolam) should be advised not to operate motor vehicles or dangerous machinery, or climb dangerous heights until it is established that they do not become drowsy or dizzy, while receiving Alzam. In these situations, impaired decision-making could lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:

The maximum recommended dosage should not be exceeded.

The optimum dosage of Alzam (alprazolam) should be individualized based upon the severity of the symptoms and individual patient response. In patients who require higher doses, dosage should be increased cautiously to avoid adverse effects.

When higher dosage is required, the evening dose should be increased before the daytime doses. In general, patients who have not previously received psychotropic medications will require lower doses than those previously treated with minor tranquillizers, antidepressants, or hypnotics or those with a history of chronic alcoholism.

It is recommended that the general principle of using the lowest effective dose be followed. Patients should be periodically re-assessed and dosage adjustments made, as appropriate.

USUAL STARTING DOSAGE* USUAL DOSAGE RANGE

Anxiety 0,25 to 0,5 mg given three times daily 0,5 to 4,0 mg daily, given in divided doses

Anxiety associated with depression 0,5 mg given three times daily 1,5 to 4,0 mg daily, given in divided doses

Geriatric patients or in the presence of debilitating disease 0,25 mg given two to three times daily 0,5 to 0,75 mg daily, given in divided doses; to be gradually increased if needed and tolerated.

Panic related Disorders 0,5 – 1,0 mg given at bedtime The dose should be adjusted to patient response. Dosage adjustments should be in increments no greater than 1 mg every 3 to 4 days. Additional doses can be added until a three times daily or four times daily schedule is achieved. Maximum of 10 mg daily

* If side effects occur, the dose should be lowered.

Treatment Period:

Treatment should be as short as possible. The patient should be re-assessed regularly and the need for continued treatment should be evaluated, especially in the case of a patient being symptom free.

The overall duration of treatment should, generally, not be more than 8 – 12 weeks, including a tapering-off process. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient’s status.

Discontinuation Therapy:

The dosage should be reduced slowly to minimise withdrawal symptoms. It is suggested that the daily dosage of Alzam be decreased by no more than 0,5 mg every three days. Some patients may require an even slower dosage reduction.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

Side effects:

Side effects, are generally observed at the beginning of therapy and usually disappear upon continued medication or decreased dosage. In patients treated for anxiety, anxiety associated with depression, the most common side-effects to Alzam (alprazolam) were drowsiness, sedation and ataxia. Drowsiness is more common in elderly and debilitated patients and in patients receiving high doses.

Less common side-effects are:

Co-ordination disorders, tremor, lethargy, ataxia, blurred vision, memory impairment/amnesia, insomnia, nervousness/anxiety, depression, headache, autonomic manifestations, change in mass and various gastrointestinal symptoms.

The following side-effects have also been reported:

Stimulation, agitation, irritability, concentration difficulties, confusion, hallucinations, other adverse behavioural effects, musculoskeletal weakness, dystonia, fatigue, slurred speech, anorexia, changes in salivation, changes in libido, menstrual irregularities, incontinence, urinary retention, abnormal liver function, jaundice, blood disorders, increased intra-ocular pressure and hypersensitivity reactions.

Amnesia and paradoxical excitation may occur. In the case of acute, hyperexcitability states, the medicine should be discontinued.

Precautions:

The usual precautions for treating patients with impaired renal or hepatic function, pulmonary disease and limited pulmonary reserve should be observed.

The safety and efficacy of Alzam (alprazolam) has not been established in children under the age of 18 years. Paradoxical reactions such as excitement and irritability may occur in children. Smaller children are more prone to these reactions.

Alzam is not recommended for the primary treatment of psychotic illness. Alzam should of be used alone to treat depression or anxiety with depression; suicide may be precipitated in such patients. Alzam should be used with extreme caution in patients with a history of alcohol or drug abuse.

Dependence:

There is a potential for abuse and the development of physical and psychic dependence, especially with prolonged use and high doses. The risk of dependence is also greater in patients with a history of alcohol or drug abuse.

Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, mild dysphoria, insomnia, muscle and abdominal pain, extreme anxiety, tension, restlessness, confusion, irritability, vomiting, sweating and tremor.

In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.

These signs, and symptoms, especially the more serious ones are generally more common in those patients who have received excessive doses over an extended period of time. However, withdrawal symptoms have also been reported following abrupt discontinuance of benzodiazepines taken at recommended therapeutic levels. Consequently abrupt discontinuation should be avoided and a gradual tapering in dosage followed. Special care may be needed in epileptic patients in whom the initiation or abrupt withdrawal has provoked seizures.

Particular caution should be exercised with the elderly and debilitated who are at special risk of oversedation, respiratory depression and ataxia (the initial oral dosage should be reduced in these patients).

Reboundeffects:

A transient syndrome, whereby the symptoms that led to treatment with Alzam recur in an enhanced form, may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually.

Duration of treatment:

The duration of treatment should be as short as possible (see Dosage), but should not exceed eight to twelve weeks in case of anxiety, including the tapering-off process. Extension beyond these periods should not take place without re-evaluation of the situation. It may be useful to inform the patient, when treatment is started, that it will be of limited duration and to explain precisely how the dosage will be progressively decreased.

Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms, should they occur while the product is being discontinued.

Interactions:

Alzam (alprazolam) produces additive Central Nervous System depressant effects when co-administered with medicines such as barbiturates, alcohol or other central nervous system depressants. Patients should be cautioned regarding the additive effect of alcohol.

The steady state plasma concentrations of imipramine and desipramine have been reported to be increased with the concomitant administration of Alzam (alprazolam). Pharmacokinetic interactions of Alzam with other medications have been reported. The clearance of Alzam can be delayed by the co-administration of cimetidine or macrolide antibiotics.

Alzam (alprazolam) did not affect the prothrombin times of plasma warfarin levels in male volunteers who received sodium warfarin orally.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF IT TREATMENT:

Manifestations of Alzam (alprazolam) overdosage include extensions of its pharmacological activity, namely ataxia and somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension.

Treatment is symptomatic and supportive.

IDENTIFICATION:

Alzam 0,25 mg: Round, white, biconvex tablets bisected on one side with “WC” and “787” debossed above and below the bisect respectively.

Alzam 0,5 mg: Round, peach, biconvex tablets bisected on one side with “WC” and “786” debossed above and below the bisect respectively.

Alzam 1,0 mg: Round, pale blue, biconvex tablets bisected on one side with “WC” and “785” debossed above and below the bisect respectively.

PRESENTATION:

Securitainers of 30’s, 100’s and 250’s.

STORAGE INSTRUCTIONS:

Store in tightly closed containers below 25°C and protect from light.

KEEP OUT OF REACH OF CHILDREN.

  • توسط admin در دی ۱۱, ۱۳۴۸
  • 751 بازدید
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HELMONTSKRUIEHELMONTSKRUIE

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

HELMONTSKRUIE

COMPOSITION:
Each 25 g contains:

Aloes 10,421 g
Camphor 0,586 g
Potassium carbonate 1,288 g
Rhubarb 2,576 g
Gentian 1,669 g
Valerian 1,434 g
Ginger 1,385 g
Cardamom 0,097 g
Myrrh 0,049 g
Clove Oil 0,006 g

PHARMACOLOGICAL CLASSIFICATION:
A 11.5 Laxatives.

PHARMACOLOGICAL ACTION:
Helmontskruie consists of a mixture of natural ingredients including aloes, which is a well known purgative. The numerous other herbal ingredients contain volatile oils which, together with camphor, have a carminative action and counteract any griping which may be present due to indigestion.

INDICATIONS
Constipation and indigestion.

CONTRA-INDICATIONS:
Undiagnosed abdominal pain, nausea, vomiting, habitual use and pregnancy.

DOSAGE AND DIRECTIONS FOR USE:
Add the contents of the packets, as well as that of the small packet enclosed, to a bottle of old wine; shake frequently and let it draw in the sun for about eight days. Filter through clean linen and take 30 drops (2,0 mL) with half a glass of water two or three times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Excessive cathartic effects, nausea and vomiting may occur in hypersensitive patients. The constant use of purgatives may result in water diarrhoea with excessive water and electrolyte loss. The use of the product should be discontinued.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-effects and Special Precautions”.

IDENTIFICATION:
A Reddish-brown coarse powder with a strong odour of camphor.

PRESENTATION:
Packets of 25 g.

STORAGE INSTRUCTIONS:
Store below 25°C
Protect from moisture
KEEP OUT OF THE REACH OF CHILDREN

LEWENSESSENS (Essence of Life)LEWENSESSENS (Essence of Life)

SCHEDULING STATUS:
Unscheduled

PROPRIETARY NAME
(and dosage form):

LEWENSESSENS (Essence of Life)

COMPOSITION:
Each 5 mL contains:

Cape Aloes 216,667 mg

plus the alcoholic extractives of

African Ginger 14,167 mg
Rhubarb 30,000 mg
Gentian 30,000 mg
Myrrh 20,000 mg
Galangal 10,000 mg
Turmeric 15,000 mg
Ethanol (100% ) 45,00% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 11.5 Laxatives.

PHARMACOLOGICAL ACTION:
The aloes and rhubarb have a laxative action, and the volatile oils, oleo resins, aloins, and other bitter extractives are carminative and also have the effect of stimulating alimentary canal movement.

INDICATIONS:
Adults:
Constipation, stomach disorders resulting from incorrect diet or excessive eating or drinking, and bad breath resulting from an inactive stomach.
For children:
Distended stomach, constipation, stomach cramps.

CONTRA-INDICATIONS:
This product should not be taken by persons with symptoms of appendicitis or severe abdominal pains, nausea and vomiting, and during pregnancy.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
One medicine measure (5 mL) taken night and morning after meals. Lewensessens (Essence of Life) is bitter and strong, and therefore some people will find it necessary to take it with cold water or beef tea.
Children:
Half to one medicine measure (2,5 – ۵ mL).

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
This product when taken as recommended does not present any side-effects but as in the case of most laxatives excessive or prolonged use may be injurious to heath.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Excessive dosage will bring about diarrhoea, nausea and vomiting, which can be treated by discontinuing use of Lewensessens (Essence of Life). Irritation of the urinary tract may occur, and aggravation of pre-existing inflammatory conditions. The central nervous system may be depressed leading to stupor and respiratory failure, or stimulated, leading to excitement and convulsions.
In acute poisoning, the stomach should be emptied by aspiration and lavage. A saline purgative, such as sodium sulphate (30 g in 250 mL water) should be given unless catharsis is already present. Demulcent drinks may be given. Large volumes of fluid should be given provided renal function is adequate.
As in all cases of overdoses, a doctor should be called immediately.

IDENTIFICATION:
Lewensessens (Essence of Life) is a dark brown free-flowing liquid with a bitter yet acceptable taste and a characteristic unique aroma.

PRESENTATION:
50 mL and 100 mL bottles.

STORAGE INSTRUCTIONS:
Store below 25°C.
Keep container tightly closed.
KEEP OUT OF REACH OF CHILDREN.

SB 3 TRIPLE ACTION PILLS (Tablet)SB 3 TRIPLE ACTION PILLS (Tablet)

SCHEDULING STATUS:
Non-scheduled

PROPRIETARY NAME:
(and dosage form)

SB 3 TRIPLE ACTION PILLS (Tablet)

COMPOSITION:
Each tablet contains

Phenolphthalein 150 mg
Jalap Resin 16,2 mg
Aloin 16,2 mg
Oleoresin of capsicum 0,6 mg
Propyl paraben (preservative) 0,003%
Methyl paraben (preservative) 0,007%


PHARMACOLOGICAL CLASSIFICATION:
A 11.5 Laxatives

PHARMACOLOGICAL ACTION:
Phenolphthalein and Aloin stimulate the accumulation of water and electrolytes in the colon and thus increases intestinal motility. Jalap Resin has a strong purgative and irritant action. Capsicum Oleoresin has a carminative action.

INDICATIONS:
For the relief of constipation.

CONTRA-INDICATIONS:
Not to be taken by pregnant women, or while breast feeding. Hypersensitivity to any of the ingredients.

WARNINGS:
This medicine should not be used in the presence of abdominal pain, nausea or vomiting. Frequent or prolonged use of this preparation may result in dependence on laxatives. If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a doctor before using a laxative. If the recommended use of this product for 1 week has had no effect, discontinue use and consult a doctor.

DOSAGE AND DIRECTIONS FOR USE:
Adult dose: One or two tablets to be taken with water at night when necessary.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
In rare cases a rash may occur due to allergy to Phenolphthalein, which can also colour alkaline faeces red.
The stated dose should not be exceeded.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In case of an overdosage, immediately give at least 25 times the amount of activated charcoal thoroughly mixed in water.

IDENTIFICATION:
Brown, sugar coated tablet.

PRESENTATION:
10 tablets cellophane wrapped, in outer carton.

STORAGE INSTRUCTIONS:
Store in a cool, dry place below 25°C. Keep out of reach of children.

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