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FG TROCHES MEIJI



FG TROCHES MEIJI



COMPOSITION

Each troche contains :
Fradiomycin                             2,5 mg (potency)
Gramicidin                                1,0 mg (potency)


PHARMACOLOGY

Fradiomycin and Gramicidin are antibiotic that acted bactericidal, active to staphylococci and prevention of postoperative (oral surgery) infections.


DOSAGE

in general, admiister 1 or 2 troches to adult and 1 troches to children 4 to 5 times a day. The troches should be dissolved in the oral or buccal cavity or under the tongue.


PRECAUTION

1)      Before use of this product, as a rule, confirm bacterial sensitivity to prevent development of resisteant bacteria. The period of administration should restricted to sithin the minimum requirement.
2)      Do not administer the troches for more than one week.
3)      Discontinue treatment upon the onset of hypersensitivity reaction.
4)      Use in elderly.
The product should be administered carefully to elderly patients, since arderse reaction such as avitaminosis are likely to occur.


ADVERSE REACTION

Black hairy tongue, oral muosal redness, glossitis may infrequently occur. Rarely, symptoms of vitamin K deficiency, such as protrombinemia and bleeding tendency and of vitamin B deficiency, suc as glossitis, stomatitis, anorexia and neruritis, may occur. These symptoms are likely to occur in poorly nourished, aged or emaciated patients.


CONTRAINDICATION

Do not administer the troches to patients with a history of hypersensitivity reaction to any component of the product and patiens with history of hypersensitivity reactions to aminoglycosides such as streptomycin, kanamycin, gentanicin and fradiomycin or bacitracin.


STORAGE

Store at a cool and dry place (150 – 250C)


PRESENTATION

Box of 12 strips @ 10 troches

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DRAMAMINE dimenhydrinate bp



DRAMAMINE

DIMENHYDRINATE BP 50 mg



COMPOSITION

Each tablet contains :
Dimenhydrinate BP                   50 mg


INDICATION

Prevention and relief of motion sickness and treatment of vertigo, nausea or vomiting associated with : electroshock therapy, anaesthesia and surgery, labyrinthine disturbances, radiation sickness and post fenestraton syndrome.


WARNINGS
Caution should be used when DRAMAMINE is given in conjuction with certain antibiotics which mah cause ototoxicity, since DRAMAMINE is capable of masking ototoxic symptoms and irreversible state may be reached

Although clinical studies in pregnant women have not indicated that DRAMAMINE increases the risk of foetal abnormalities, it, like any drug, should be used durngi pregnancy only it benefits outweigh the risk. As small amounts of DRAMAMINE are excreted in breast milk, benefits of therapu must be weighed against potential adverse reactions in nursing infants.


ADRVERSE REACTIONS

Drowsiness may be experienced by some patients, especially those on high dosage, although this effect frequently is not undersirable in some conditions for which the drug is used. However atiens should be cautioned against operating automobiles or dangerous machinery while taking DRAMAMINEbecause of possible drug-associated drowsiness.


DOSAGE AND ADMINISTRATION

Tablets :
DRAMAMINE is available as  a 50 mg tablet
Adults  : The adults therapeutic and prophylactic dose is 50 to 100 mg three or four times daily.
Children :
Ages 6-8 years             : 12,5 mg to 25 mg (1/4 to1/2 tablet)
                                      Two or three times daily
Ages 8-12 years           : 25 to 50 mg (1/2 to one tablet)
                                      Two or there times daily
Ages 12 years and older : 50 mg (one tablet)
                                      Two or three tines daily
For prevention of motion sickness the firs dose should be given 30 menute before departure


STORAGE
Store below 300C
Keep out of reach of children


PRESENTATION
Box @ 100 tablets (10 strip @ 10 tablet)
PT TAISHO PHARMACEUTICAL


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Neuralgin RX (methampirone thiamine pyridoxine cyanocobalamin, trimethylxanthine)



NEURALGIN RX

Methampirone, Thiamine HCl, Pyridoxine HCl, Cyanocobalamin, Trimethylxanthine.


COMPOSITION

Each film coaterd caplet contains :
Methampyrone                                     500 mg
Thiamine HCl                                                     50 mg
Pyridoxine HCl                                       10 mg
Cyanocobalamin                                                  10 mg
Trimethylxanthine                                                 50 mg


PHARMACOLOGY

Methampyrone is a potent nonnarcotic analgesic – antipyretic drug. It is a pyrazolon derivative with therapeutic efficacy equivalent to that of acetosal, the standard drug for  the nonnarcotic analgesic – antipyretic class. It cause less gastric irritation that acetosal and does not produce the acid – base or metabolic effect of salicylate.
Hewever, it has been implicated for many heares to cause a high incident of agranulocytosis. An epidemiologic study of international scale involving about 30 million people had been especially designed to study this matter.
The study was completed just recently and the results showed that methampurone , in fact, accounted for only a very low incidence of agranulocytosis.
Trimethylxanthine is commonly added to an analgesic as an analgesic adjuvant. In a dose of 50 mg or more, trimethylxanthine has been shown to enhance the analgesic efficacy of acetosal adan acetaminophen; in this case methampyrone should not be an exception.
Thiamine HCl, pyridoxine HCl and cyanocobalamin are neurotropic vitamins; deficiency of any of these vitamins may cause some form of neurologic disturbance.


INDICATIONS
Relief of mild to severe pain, such as headache especially tension headache, myalgia, arthralgia, neuralgia, lumbago, tootache, menstrual pain, pain from cancer, biliary and renal colic, postpartum pain, postoperative pain.


CONTRAINDICATION
1.      Hypersensitivity to methampurone and other nonsteroidal anti inflammatory drugs.
2.      Concomitant administration with chlorpromazine (may result in serious hypothermia)


PRECAUTIONS
1.      Use with caution in        - peptic ulcer (active/history)
- hemostatic defect (avoid) or anticoagulant therapy
- severe liver disease
- pregnancy (not recommended) especially late pregnancy.
- nursing mother (not recommended)
- infants
- history of blood dyscasia.
             
2.      Discontinue the drug if the following develops :
·        Fever, some throat or stomatitis (may indicated agranulocytosis, hematologic evaluation should be performed)
·        Evidence of peptic ulceration or gastrointestinal bleeding.


ADVERSE REACTIONS

The most frequent are gastrointestinal symtoms, such as nausea, vomiting, epigastric discomfort etc.
NERUALGIN RX may also cause hypersensitivity reactions, e.g. skin rashes and pruritus. Side effect occuring rarely are gastrointestinal bleeding and ulceration, leukopenia and agranulcytosis.


DOSAGE
Adult                : 1-2 caplets 3 to 4 times daily
Children           : ½ -1 caplet 3 to 4 times daily
If gastrointestinal discomfort occurs, administer NEURALGIN RX with or after meals


STORAGE
Sore below 300C


PRESENTATION

Box of 10 strips x 10 film coated caplets.
Reg.No. DKL8511603809A1
PT KALBE FARMA




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OTOLIN Ear Drop


OTOLIN

Chloramphenicol,
Polymyxin B. Sulphate,
Benzocaine,
Nipagin

Ear drop


COMPOSITION

Each mL contains :
Chloramphenicol                                            5 %
Polymyxin B. Sulphate,             10.000 IU
Benzocaine                                                    1 %
Nipagin                                                         1 %


PHARMACOLOGY

Chloramphenicol is an antibiotic, which has a wide range of antimicrobial actinity including both Gram-positive and Gram-negative microorganisms. Topically and in ear drops Chloramphenicol is of value and is often effective even when such microorganisms as P. vulgaris and Ps. Aeruginosa which are resistant to many antibacterial agents are present.
Polymyxin B. sulphate is an antibiotic of choice in the treatment of incections caused by susceptible strains of Gram-negative bacteria including many starins of Ps. Aeruginosa, which are the mst destructive pathogens found in topical and ear infections.
This combination ensures eradication of the pathogenic microorganisms, and reduces the risk of developing resesteance to one of antibiotics. Benzocaine help relieve the pain, while nipagin in concretration of 1 % gives a strong antiseptic effect.


INDICATIONS

OTOLIN  is indicated in the treatment of acute and chronic otitis externa caused bay microorganisms susceptible to Chloramphenicol and Polymyxin B. sulphate.


CONTRAINDICATION

OTOLIN is contraindicated in persons sensitive to any of ists components.


PRECAUTIONS

Prolonged use may result in overgrowth of non-suciptible microorganisms. If sensitivity or irritation occurs, medication should be discontinued promptly.


DOSAGE

3 -4 drops in effected ear 3 or 4 times daily.


STORAGE BELOW 300C
PROTECT FROM LIGHT

 

PRESENTATION

Bottle of 10 mL
Reg. No. DKL7211639748A1
PT KALBE FARMA


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KSR potassium Chloride



KSR

Potassium Chloride
Potassium supplement


COMPOSITION

Each film-coated SR tablet contains Potassium Chloride 600 mg


MODE OF ACTION

KSR is a film-coated preparation of potassium chloride formulated for slow release.
Each tablet contains 600mg of potassium chloride which is equivalent to 8 mili-equivalent each of Potassium [K+] and Chloride [Cl-]. The show and sustained release over a period of 6 hours precludes high concentration of potassium chloride against a localized area of the gut wall which might irritate or damage the mucosa. The sustained relase providers conditions of maximum gastric tolerance and effective absorpstion for the treatment of all types of potassium deficiency, whether hypochloraemic alkalosis. KSR does not alter normal kidney function; can be used in all age groups; replaces the essential chloride anion and potassium and so prevents hypochloraemic alkalosis. During KSR administration, laboratory monitoring of serum electrolyte level should be done periodically.


INDICATIONS
For treatment and specific prevention of hypokalemia.


DOSAGE and ADMINISTRATION

An average dose is 1 or 2 tablet two or three times daily, each tablet swallowed whlle with little water, preferably during meals. Where KSR is administerd routinely with an average daily maintenance dose of an oral diuretic agent, 1-2 tablet daily may be sufficient.


WARNINGS

If a patien under treatment with KSR develops severe vomiting, severe abdominal pains or flatulence, or gastoristesinalhaemorrhage, the preparation should be withdranwn at once. To prevent the risk of hyperkalemia, potassium supplements should not be administered with potassium sparing diuretic agent such spironolactone, triamterene or amiloride. In case of metabolic acidosis, hypokalemia should not be treated with potassium chloride but with a potassium salt containing an alkalosing anion [e.g potassium bicarbonate].


PRECAUTIONS
In patien with impaired renal function , special care should be exercised when prescribing potassium salt because of the risk of hypokalaemia. The serum electrolytes should be monitored in these patiens and also in patiens with congestive heart failure, especially if under treatment with digitalis, in whom hypokalemia should be avoided.


ADVERSE RACTIONS

Oral potassium preparatons can provoke gastrointestinal disturbance (e.g. nausea vomiting, abdominal pain, diarrhea). In rare cases, KSR may also cause these side-effect. In this evevnt, reduction in dosage or withdrawal of drug may be necessary.


CONTRAINDICATION
Advanced ernal failure, untreated Addison;s disease, acute dehydration, hyperkalemia, in the presence of obstruction in the digestivetract (e.g. resulting from compression of the oesophagus due to dilation of the left atrium or from stenosis of the gut). The administration of KSR  in such a situation could be conceivably give rise to ulceration or perforaton.


STORAGE

Store in a dry place below 250C


PRESENTATIONS
Bottle of 100 film coated SR tablets
Box of 10 x 10 film coated SR tablet in strip

PT MERCK
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Urispas 200 Flavoxate hydrochloride



URISPAS 200

Flavoxate Hydrochloride 200mg



COMPOSITION

Each film coated tablet contains flavoxate hydrochloride 200mg


MECHANISME OF ACTIONS

Flavoxate hydrochloride is a flavone derivative.
The basic action of Urispas is the relaxation of smooth muscle fibres of the urinary tract


INDICATIONS

Urispas is indicated for the symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as many occur in cystitis, prostatitis, urethritis, urethrocystitis, and urethrotrigonitis.


DOSAGE AND ADMINSTRATION
Adult and children over 12 years of age :  200 mg 3 – 4 times a day.
With improvement of symptoms, the dose may be reduced.


PRECAUTIONS
Urispas should be given cautiously to patiensts with suspected glaucoma. The drug should only be used during pregnancy if the anticipated benefits outweigh any risk. Not recommended for infants and children under 12 years of age since safety and efficacy studies in this age group are not completed.
In the event of drowsiness or blurred vision, the patients should not operate a motor wehicle or any machinery, and refrain from participating in activites requiring alertness. If overdosage occur, maximus 4 hours after overdosage, evacuation of the stomach should be performed. If overdosage is extreme, or there is a delay in removing the drug from the stomach, administration of a parasympathomimetic drug should be considered. Administration in nursing mother only if clearly needed.


ADVERSE REACTION
Nausea, vomiting, dry mouth, nervousness vertigo, headache, drowsiness, blurred vision, increased ocular tension, disturbance in eye accommodation, mental confusion, dysuria, tachycardia, palpitation, hyperpurexia, eosinophilia, leukopenia, urticarial and other dermatoses.


CONTRAINDICATION

URISPAS is contraindication in pationts who have any of the following conditions; pyloric or duodenal obstrucion, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.


STORAGE
Keep in a cool and dry place


PRESENTATION
Box, 3 blister @10 film coated tablet
RECODARTI S.p.A.



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ASPAR-K supplement potassium aspartate



ASPAR-K

Potassium aspartate preparation


COMPOSITION AND DESCRIPTION

Generic name : Potassium L-aspartate

Product’s name
Content of Potassium L-aspartate
Description of the product
ASPAR-K
300 mg per tablet (K : 1,8 mEq)
White film-coated tablet


ACTIONS

PHARMACOLOGICAL ACTIONS :
A potassium ion, one of the main electrolytes in the cell, has actions such as to induce the membrane potential, to maintain the osmotic pressure and to control the acid-base equilibrium.
When the red blood cell is employed as a sample to examine the transport of potassium into the tissues, potassium L-aspartate proves a beter intake by the tissues than potassium chloride.

ABSORPTION AND EXCRETION :
When the amount of Potassium L-aspartate equivalent to 20 mEq/kg/day of potassium was administered for 32 days to rats fed on food lacking porassium for 24 days, the eman amount of potassium excreted in the feces was 26.1 µEq/head/day. Namely, the absorption rate of potassium from the intestines was not less than 99,5% because the mean administration amount of potassium was 5,497 µEq/head/day.

TOXICOLOGY AND TERATOLOGY
1.      Acute toxicity :
The LD50 of Potassium L-aspartate in male rats is not less than 10000 mg/kg, 4,061 mg/kg, 1500 mg/kg and 667 mg/kg by oral, subcutaneous, intraperitoneal and intravenous routes, respectively.
2.      Chronic toxicity :
After administration fo 4g/kg
3.      Teratology
Fetal toxicity in mice and rats was evaluated in accordance with the Measurements for Safety of Drug by the Japanese Ministry of Health & Welfare, and no significant difference was observed between administration and control group.


INDICATIONS
Potassium supplement in the following diseases and symptoms accompanied with the imbalance of electrolytes :
Cardiac diseases
Liver diseases
Periodic tetraplegia due to hypokalemia,
Hypokalemia due to prolonged administration of antihypertensi diuretics, adrenal cortical steroid, digitalis and insulin
Other disorder of potassium metabolism (pre- and post-operative course, diarrhea, vomiting)


ADMINISTRATION AND DOSAGE

Take 1 to 3 tablets three times daily
The dose may be increased according to the secerity of symptoms and condition of patients.


CAUTION ON USE
1.      CONTRAINDICATION :
1)      Patiens with Addison;s disease untreated
2)      Patient with hyperkalemia
3)      Patient with hypersensitivity to the drug components

2.      USES WITH CAUTION
On administration to those patiens with advanced hypo functioned or damaged kidneys, including those suspected of such disorders, whose serum and urnary electrolytes should be carefully examined.

3.      ADVERSE REACTION :
a.       Digestive system     : anorexia and gastric disturbances have been encountered.
b.      Heart                      : precordial heavy feeling has been noted.

4.      IT IS ADVISABLE NOT TO ADMINISTER THE DRUG to premature infants, newborns and infats, because the drug is reported to cause at 250 mg/kg or more as asparticc acid some histopathological change in the nucleous arciformis of the hypothalamus in mice and rats at the age of 3 week or below.

5.      INTERACTION :
Since the following drug may cause hyperkalemia, concurent use with the should be exercised with much care
·        Antialdosterone preparation
·        triamterene


CAUTION AND HANDLING
As the tablet are hygroscopic the container and tablet must be kept in a cool and dry place


STORAGE

Store in a tigh and light-resistent container at below 300C


PRESENTATION

Box of 10 aluminium strips of 10 tablets

MITSUBISHI TANABE PHARMA CORPORATION
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