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Tuesday, December 1, 2015

Kanamycin Sulfat "Meiji"


Kanamycin is a water soluble and basic antibiotic discovered by Dr. Hamao Umezawa and others, National Institute of Health of Japan, in 1955.
Kanamycin was isolated from the culture broth of a new Streptomyces species, Streptomyces Kanamyceticus.

Kanamycin is active both in vitro and in vivo against gram-positive and gram-negative bacteria as well as acid-fast bacteria (Mycobacterium tuberculosis). It inhibits strongly the growth of these bacteria and exerts a powerful protective effect against the infections due to them. Kanamycin was proved, under the experiments with mice, rats, dogs, cats, goldfishes and monkeys, to be a substance of less acute and chronic toxicity.

KANAMYCIN Sulfate "Meiji" has been made available to the world by Meiji Seika Kaisha, Ltd., which carried on the production research of this epoch-making antibiotic from the beginning, confirming the marked therapeutic effect in the clinical trials subject to several hundred of patients.
KANAMYCIN Sulfate "Meiji" contains 0.5 g (base), 1 g (base ), 2 g (base) of Kanamycin Sulfate in a container and is prepared conforming to the Minimum Requirements of Antibiotic Products for the national assay

Physical and Chemical Properties. This preparation is a white powder of Kanamycin Sulfate. It is hygroscopic and readily soluble in water. Its pH in an aqueous solution of 50 mg (base) per ml is 6.0 to 7.5. It is reported that Kanamycin Mono sulfate has the molecular formula of C18H36N4O11H2SO4, H2O and is composed of desoxystreptamine, 6-deoxy-6-amino D-glucose and another aminohexose (kanosamine).
Pharmacology. The LD50 of intravenous Kanamycin in mice, rats and rabbits is 200 to 300 mg (base) per kg of body weight and that of intra peritoneal of subcutaneous injection in mice is about 1.700 mg (base) per kg.
Kanamycin is free from delayed or chronic toxicity. The mice tolerated 400 mg (base) per kg in 30 days subcutaneously every day, and rats 355 mg (base) per kg in 6 weeks.
Kanamycin given to dogs subcutaneously 100 mg (base) per kg once daily for 3 months and intramuscularly 150 mg (base) per kg once daily for 60 days caused no disturbances in hepatorenal and hematopoietic functions nor any other undesirable side reaction.
There appeared no toxic sign in monkeys received the continuous administration of 200 mg (base) per kg daily for 50 days.
Antimicrobial Activity and Resistance. Kanamycin is an amynoglycoside group antibiotic which activity is as bactericide, effective against gram negative bacteria including Mycobacterium tuberculosis (acid fast bacteria). Kanamycin activity against gram positive bacteri including Streptococcal is very small.
Kanamycin shows no cross-resistance with other antibiotics commonly used.
Mycrobactcrium tuberculosis resistant to one or more of Streptomycin. PAS and INH also responds to Kanamycin.
Absorption and Excretion. Kanamycin given intramuscularly attains the peak concentration in serum about 1 hour later, distributes in various organs and is excreted principally through the kidney about 50% in urine by 24 hours.
The blood concentration of Kanamycin following intramuscular administration are illustrated in the figure.

Blood concentration of KANAMYCIN Sulfate "Meiji" following a single intramuscular administration (Department of Urology, Tokyo University)
Stability. Kanamycin Sulfate and Kanamycin Monosulfate are highly stable, and their aqueous solution will maintain its full activity after standing for 2 months at room temperature. They lose no activity when heated at 100°C for 1 hour.

  • Kanamycin is used for serious infection caused by Escherichia coli, Klebsiella pneumonia, Enterobacter aerogenes, Proteus vulgaris such as:
    • Septicemia
    • Respiratory tract infection
    • Meningitis
    • Intra abdominal infection (such as Peritonitis)
    • Complicated urinary tract infection
  • Although Kanamycin is not drug of choice for Staphylococcal infection but Kanamycin can be indicated for theraphy of Staphylococcal infection if Penicillin or other less toxic drugs is contraindicated and sensitivity test and clinical consideration support the use of Kanamycin.
  • Kanamycin can be used as "second line" drug of the treatment of tuberculosis.
  • Kanamycin can be used for the treatment of Gonococcal infection resistant to Penicillin.
  • Kanamycin can be used for early treatment of serious infections if the causative organism is not yet identify between Staphylococcal and gram - negative bacteria or mixed organism.
  • This drug is not to be used for early stage of uncomplicated urinary tract infection, except if the causative organism are sensitive to Kanamycin and not sensitive to other less toxic antibiotics
  • Kanamycin is not effective against Pseudomonas aeruginosa bacteria.
  • This drug is not used for early of uncomplicated urinary tract infection, except if the causative organism are sensitive to Kanamycin and not sensitive to other less toxic antibiotic.

For parenteral used. KANAMYCIN Sulfate "Meiji" is dissolved in water for injection. The amount of solvent to be added to 0.5 g (base), 1 g (base) or 2 g (base) vial to obtain the desired concentrations are shown in the following table. The solution is so stable as to retain its potency at room temperature, but is preferable to use soon after preparation.

Intramuscular administration
The solutions of 150 to 400 mg (base) per ml are usually employed

Acute infection:
15 mg (base) per kg body weight per day is injected in 1 or 2 divided doses.
Above dosage should be adjusted according to patient condition and disease.
doses deep into the muscle.

15 mg (base) per kg body weight per day in 1 or 2 divided doses,
Above dosage should be adjusted according to patient condition and disease.

Dilution Table
added to
0.5 g
4.6 ml
3.6 ml
2.9 ml
2.1 ml
1.6 ml
0.9 ml
1 g
9.2 ml
7.2 ml
5.8 ml
4.2 ml
3.2 ml
1.7 ml
2 g
8.4 ml
6.4 ml
3.4 ml
Potency of
Kanamycin per ml
100 mg
125 mg
150 mg
200 mg
250 mg
400 mg

Patients receiving the drug should be carefully observed for sign of eight nerve damage. It is desirable to discontinue the treatment immediately when the toxic effects appear. If administration of the drug is unavoidable, the drug should he administered under carefull observation. Observation should be done to renal function, audiogram, before and during treatment to the patient with renal damage. Old patient, patient with tinnitus or vertigo and patient used ototoxic before, should be carefully observed due to possibility of eight nerve damage. In pregnancy, should be used with caution.

Administration of Kanamycin may cause impairment of the auditory portion of the eight nerve (mainly cochlear function damage) with sign such as tinnitus, hearing difficulty and vertigo. Nephrotoxic effect may be seen in some patients. If the sign of renal damage occur, the drug should be discontinued. Administration of the drug may cause transient headache and numbness of lips, neurotoxicity, nephrotoxicity, eosinophilia, rash, pruritis, fever, paresthesia.

The drug should be discontinued if a hypersensitivity reaction occurs. In patients with hypersensitive to one of aminoglycoside group, such as: Fradiomycin, Streptomycin, dihydrostreptomycin, Kanamycin, Gentamycin, the drug should be avoided. In pregnant patient the drug should be administered under careful observation because of the possibility of inducing a damage to the eight nerve of new born.

Concurrent administration of blood substitute such as dextran and sodium alginate with Kanamycin should be avoided because of the possibility of the intensifying effect of these nephrotoxic drugs. The drug should he administered carefully when it is necessary to combine with anesthetics or muscular relaxant. since the combinations with such drugs may cause respiratory depression due curare action.

The preparation may be stored at room temperature and should be used before expiration date stated on the label.

KANAMYCIN Sulfate "Meiji" is supplied in a vial containing of 0.5 g (base), 1 g (base) or 2 g (base) as Kanamycin Sulfate

KANAMYCIN Sulfate "Meiji" 0.5 g (Base) / vial Reg. No. DKL7415300l44Bl
KANAMYCIN Sulfate "Meiji"   1 g (Base) / vial Reg. No. DKL72l5300144A2
KANAMYCIN Sulfate "Meiji"   2 g (Base) / vial Reg. No. DKL7815300144Cl



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Monday, November 30, 2015

Pantozol i.v.

Pantozol® i. v.
Active ingredient: Pantoprazole sodium sesquihydrate

Each vial contains 45.1 mg Pantoprazole sodium sesquihydrate (equivalent to pantoprazole 40 mg)

Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid the stomach by specific action on the proton pumps of the parietal cells.
Pantoprazole is converted to its active form in the acidic environment in the parietal cells where its inhibits the H+, K+-ATPase enzyme, i.e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose-dependent and affects both receptor inhibitors, treatment with pantoprazole causes a reduced acidity in the stomach and thereby an increase in gastrin in proportion to the reduction in acidity. The increase in gastrin reversible. Since pantoprazole binds to the enzyme distal to the cell receptor level, the substance can affect hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same whether the product is given orally or intravenously.

  • Duodenal ulcer
  • Gastric ulcer
  • Moderate and severe cases of inflammation of the esophagus (reflux esophagitis)
  • For the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison-Syndrome or other neoplastic conditions

The intravenous administration of Pantozol i.v is recommended only if oral application is not appropriate.

-Recommended dosage
Duodenal ulcer; gastric ulcer; moderate and severe reflux esophagitis
The recommended intravenous dosage is one vial (40 mg pantoprazole) Pantozol i.v. per day
Long term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions
Patients should start their treatment with a daily dose of 80 mg Pantozol i.v. Thereafter, the dosage can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily, A temporary increase of the dosage above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control.
In case a rapid acid control is required, a starting dose of 2 x 80 mg Pantozol i.v. is sufficient to manage a decrease of acid output into the target range (‹ 10 mEq/h) within one hour in the majority of patients. Transition from oral to i.v, and from i.v to oral formulations of gastric acid inhibitors should be performed in such manner to ensure continuity of effect of suppress on of acid secretion.
-Instruction for use/ handling
A ready-to-use solution is prepared by injecting 10 ml of physiological sodium chloride solution into the vial containing the dry substance. This solution may be administered directly or may be administered after mixing with 100 ml physiological sodium chloride solution or 5% Glucose.

After preparation the solution must be used within 12 hours. From a microbiological point of View, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at not more than 25°C

Pantozol i.v. should not be manufactured or mixed with solvents other than those stated.
As soon as oral therapy is possible, treatment with Pantozol i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead.

The drug should be administered intravenously over 2 - 15 minutes,

Any product that has remained in the container or the visual appearance of which has changed (e.g. if cloudiness or precipitation is observed) has to be discarded.

The contents of the vial is for single use only.

Pantozol i.v. should generally not be used in cases of known hypersensitivity to the constituent.

The intravenous administration of Pantozol i.v. is recommended only if oral application is not appropriate.
Pantoprazole is not indicated for mild gastrointestinal complaints such as nervous dyspepsia.
Prior to treatment the possibility of malignancy of gastric ulcer or a malignant disease of the esophagus should be excluded as the treatment With pantoprazole may alleviate the symptoms of malignant ulcers and can thus delay diagnosis.
Diagnosis of reflux esophagitis should be confirmed by endoscopy.
The daily dose of 40 mg pantoprazole should not be exceeded in elderly patients or in those with impaired renal function
In patients with severe liver impairment the daily dose has to be reduced to 20 mg pantoprazole. Furthermore, In these patients the liver enzymes should be monitored during Pantozol i.v. therapy. In case of a rise of the liver enzymes Pantozol i.v. should be discontinued.
To date there has been no experience with treatment in children.

Pregnancy and Lactation
Clinical experience in pregnant women is limited in animal reproduction studies, signs of slight fetotoxicity were observed at doses above 5 mg/kg. There is no information on the excretion of pantoprazole into human breast milk. Pantoprazole should only be used when the benefit to the mother is considered greater than the potential risk to the foetus/ baby.

Effect on the ability to drive and to use machines
There are no known effects on the ability to drive and use machines.

Changes in absorption should be observed when drugs whose absorption 15 pH-dependent e.g. ketoconazole, are taken concomitantly
The active ingredient of Pantozol i.v. is metabolized in the liver via the cytochrome P450 enzyme system. An interaction of pantoprazole With other drugs or compounds which are metabolized using the same enzyme system cannot be excluded. No clinically significant interactions were, however, observed in specific tests with a number of such drugs or compounds, namely carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline, warfarin and an oral contraceptive.
Although no interactian during concomitant administration of phenprocoumon or warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in INR have been reported during concomitant treatment in the post-marketing period. Therefore, in patients being treated with coumarin anticoagulants, monitoring of prothrombin time/INR is recommended after initiation, terminatian or during irregular use of pantoprazole.
There were also no interactions with concomitantly administered antacids.

There are no known symptoms of overdosage in man.
Doses up to 240 mg i.v. were administered over two minutes and were well tolerated. In the case of overdosage with clinical signs of intoxication, the usual rules of intoxicatron therapy apply.

Very Rare
(‹1/10,000,incl.isolated reports)
Organ System
Blood and lymphatic systemLeukopenia; Thrombocytopenia
Gastrointestinal disordersUpper abdominal pain; Diarrhoea; Constipation; FlatulenceNausea/ VomitingDry Mouth
General disorders and administration site conditionsInjection site thrombophlebitis; Peripheral edema
Hepatobiliary disordersSevere hepatocellular damage leading to jaundice with or without hepatic failure
Immune system disordersAnaphylactic reactions including anaphylactic shock.
InvestigationsIncreased liver enzymes (transaminases, γ-GT); Elevated triglycerides; Increased body temperature
Musculoskeletal, connective tissue disordersArthralgiaMyalgia
Nervous system disordersHeadacheDizziness; Disturbances in vision (blurred vision)
Psychiatric disordersMental depression
Renal and urinary disordersInterstitial nephritis
Skin and subcutaneous tissue disordersAllergic reactions such as pruritus and skin rashUrticaria; Angioedema; Severe skin reactions such as Stevens-Johnson Syndrome, Erythema multiforme, Lyell-Syndrome; Photosensitivity

Box, 1 vial
Reg. No. DKI0253300344A1

Keep below 25°C
Keep container in the outer carton.

On Medical Prescription Only

Keep medicament out of reach of children!

Imported by:

Under license from and manufactured by:
Nycomed GmbH
D 78467 Konstanz
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Sunday, November 29, 2015

Harnal D Tablet

Harnal® D 0.2 mg Tablet

Tamsulosin hydrochloride is a white crystal. It is freely soluble in formic acid, sparingly soluble in water, slightly soluble in acetic acid (100), and very slightly soluble in ethanol (99.5)

1Pharmacological Effects
(1)Effects in humans
In a receptor binding assay using human prostate preparations, tamsulosin hydrochloride was 2.2 times more potent than prazosin hydrochloride and 40 times more so than phentolamine mesylate in α1-receptor blocking activity.
(2)Effects in animals
1) Blockade of α-adrenergic receptors
In a receptor binding assay using isolated rat cerebral membrane and an in vitro experiment using isolated rabbit aorta, tamsulosin hydrochloride inhibited α1-receptors selectively and competitively. Its action was 1/2.2 to 22 times more potent than prazosin hydrochloride and 45 to 140 times more potent than phentolamine mesylate.
In vitro experiments using isolated rabbit aorta, isolated rat vas deferens and isolated guinea pig intestine, tamsulosin hydrochloride proved to be 5,400 to 24,000 times more selective for α1-receptors than for α2-receptors.
2)Effect on the lower urinary tract (urethra and urinary bladder) and prostate In a receptor binding assay using isolated smooth muscle from the rabbit urethra, prostate and urinary bladder base, tamsulosin hydrochloride was 23 to 98 times more potent than prazosin hydrochloride in α1-receptor blocking activity, and 87 to 320 times more potent than phentolamine mesylate. In anesthetized dogs, the drug inhibited the α1-agonist (phenylephrine)-induced increase in intrauretheral pressure with 13 times greater potency than the increase in diastolic blood pressure.
3)Improvement of bladder outlet obstruction
In anesthetized male dogs, tamsulosin hydrochloride decreased urethral pressure in the prostatic zone of the intraurethral pressure curve. In anesthetized rats, however, the drug did not affect rhythmic bladder contraction or threshold intravesical pressure.
2.Mechanism of action
Tamsulosin hydrochloride decreases urethral pressure in the prostatic zone of the intraurethral pressure curve by inhibiting α1-receptors in the urethra and prostate, thus improving bladder outlet obstruction associated with benign prostatic hyperplasia.

Metabolism and excretion
Single doses of Tamsulosin hydrochloride at 0.1 to 0.6 mg were orally administered to healthy male adults. The excretion rate of the unchanged drug in the urine up to 30 h after administration remained almost constant at 12 to 14%. No significant changes in the excretion rate after repeated administrations were observed.

Bladder outlet disturbance associated with benign prostatic hyperplasia.

Harnal® D Tablet are contraindicated in the following patients:
  1. Patients with a history of hypersensitive reactions to this drug.
  2. Patients who take vardenafil HCl hydrate (See "Drug Interactions")
  3. Severe hepatic insufficiency
  4. Severe impaired renal function (An excessive increase in plasma drug concentration may be induced in patients with impaired renal function, but complete pharmacokinetic data in such patients are not yet available. Therefore, patients with severe impaired renal function should not use this drug.)

  1. Careful Administration (Harnal® D Tablet should be administered with caution in the following patients.)
    1. Patients with orthostatic hypotension [Symptoms may be exacerbated.]
    2. Patients with hepatic dysfunctions [Plasma drug concentrations may be increased.]
    3. Patients with mild to moderate renal dysfunction [An increase in plasma drug concentrations may result.]
    4. The elderly patients [See "Geriatric Use"]
  2. Important Precautions
    1. The tablets disintegrate in the mouth, but are not absorbed through the oral mucosa. Therefore, the patients should be instructed to swallow the dissolved tablet with saliva or a drink of water.
    2. Use with caution concerning dosage and administration. Overdosage may cause a decrease in blood pressure.
    3. Blood pressure in the orthostatic position may decrease. Patients must be watched for any changes in blood pressure occurring with postural change. 
    4. The drug does not eliminate the cause of the disease, but gives symptomatic relief. If the expected response does not result, surgical therapy or other alternative procedures should be considered.
    5. Since the drug may produce dizziness, patients should be cautioned about driving, operating machinery or performing hazardous tasks.
    6. Before the start treatment, patients should be asked whether they are taking any antihypertensive drugs. If any such drugs are used, blood pressure during treatment should be monitored closely. If a decrease in blood pressure is observed, the dose should be reduced, the treatment discontinued, or other appropriate measures taken.
    7. Intraoperative Floppy Iris Syndrome (IFIS, a variant of small pupil syndrome) considered to be due to alpha-1 blocking action has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Opthalmologist should be aware of possible occurrence of IFIS during cataract surgery.
    8. Use in patients with micturition syncope is not advised
  3. Geriatric Use; The elderly are more likely to have a renal dysfunction. Such patients should be carefully monitored. If efficacy is not noted at 0.2 mg, the dose should not be increased further, and other appropriate measures must be taken.
  4. Cautions in Use
    1. Caution in dispensing: Patients should be instructed to press the tablet out of a press-through package (PTP) and take it. [It has been reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, resulting in severe complications such as mediastinitis.]
    2. Caution in oral administration:
      1. Patients should be instructed not to chew the Harnal® D Tablet. [Prolonged release particles of tamsulosin hydrochloride are contained in the tablets. Crushing or chewing the tablets may destroy the prolonged release particles and may cause changes in pharmacokinetics.]
      2. The tablets can be soaked in saliva on the tongue, lightly mashed between the tongue and hard palate, and then swallowed with saliva alone.
      3. The tablets should not be taken without water if the patient is lying down.

Adverse reactions (including abnormal clinical laboratory values) appeared in 104 cases (2.2%) out of 4,724 used for the analysis of safety at the time of approval and during post-marketing surveillance for Harnal® Capsules. The most frequently observed adverse reactions were dizziness and stomach discomfort (at the end of the Harnal® Capsules reexamination period).
  1. Clinically significant adverse reactions
    1. Syncope unconsciousness (Incidence unknown): As transient unconsciousnesses or etc. may appear with the decrease of blood pressure, the patient should be observed carefully. If such reactions are observed during treatment, discontinue treatment and institute appropriate medical therapy.
    2. Hepatic dysfunction or jaundice (Incidence unknown): As increases of AST (GOT), AL T (GPT), or jaundice may appear, the patient should be observed carefully. If such reactions are observed during treatment, appropriate measures such as drug discontinuation should be taken.
  2. Other adverse reactions
5% ≥ 0.1%  
‹ 0.1%
Incidence unknown
Nervous system/ PsychiatricDizziness GiddinessDizziness on standing up,
headache, sleepiness
CardiovascularBlood pressure dropped,
orthostatic hypotension.
tachycardia, palpitation
Hypersensitivity*Itching, rashUrticaria
GastrointestinalStomach discomfortNausea/vomiting, dipsosis,
obstipation, stomach heaviness, stomachache. appetite decreased,
 diarrhea, dysphagia
OthersNasal obstruction, edema,
urinary incontinence, burning sensation of pharynx, generalized fatigue
Dysgeusia, gynaecomastia, priapism
Intraoperative Floppy Iris Syndrome (IFIS)**
*    If such a reaction develops, discontinue treatment.
** During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported (see Important Precautions).

[Contraindications for co-administration] (Harnal® D Tablet should not be co-administered with the following drugs.)
DrugsSigns, Symptoms, and TreatmentMechanism and Risk Factors
Vardenafil HCl hydrateIt has been reported that concomitant use of vardenafil HCl hydrate and Tamsulosin Hydrochloride may cause hypotension or orthostatic hypotension.Since Tamsulosin Hydrochloride exhibits an α-blocking activity, the vasodilatory hypotensive action of vardenafil HCl hydrate may be enhanced by concomitant use.

[Precautions for coadministration] (Harnal® D Tablet should be administered with care when coadministered with the following drugs.)
DrugsSigns, Symptoms, and TreatmentMechanism and Risk Factors
AntihypertensivesTake precautions by decreasing doses as orthostatic hypotension may occur.Patients who take antihypertensives may experience a decrease in blood pressure when they stand up.
Sildenafil citrateIt has been reported that concomitant use of sildenafil citrate and other α-blockers may cause hypotension accompanied by subjective symptoms such as dizziness.Since Tamsulosin Hydrochloride exhibits an α-blocking activity, the vasodilatory hypotensive action of sildenafil citrate may be enhanced by concomitant use.

No cases of acute overdosage have been reported. However, acute hypotension is likely to occur after overdosage in which case cardiovascular support should be given. Blood pressure can be restored and the heart rate brought back to normal by lying the patient down.
If this does not help then volume expanders. when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be help as tamsulosin is very highly bound to plasma proteins.
Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate can be administrative.

The usual adult dosage for oral use is 0.2 mg - 0.4 mg of tamsulosin hydrochloride once daily after meals.
The dosage may be adjusted depending on the patient's age and symptoms.

Nonproprietary name:
Tamsulosin hydrochloride

Chemical name:
(-)-(R)-5-[2-[[2-(o-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide hydrochloride

Molecular formula:
C20H28N2O5S HCl Molecular weight: 444.97

Melting point:
About 230°C (decomposition)

Structural formula:

Harnal® D Tablet:
Box of 2 x 14 Tablets

Store below 30°C

"Harus dengan resep dokter"

Reg. No.: DKI0829000281A1

Manufactured by:
Astellas Tokai Co., Ltd. Shizuoka, Japan

Licenced from:
Astellas Pharma Inc., Tokyo, Japan

Packed by: Interthai Pharmaceutical Manufacturing Ltd., Bangkok, Thailand

Imported by: P.T. Astellas Pharma Indonesia, Jakarta, Indonesia
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Saturday, November 28, 2015

Vitka Infant Injeksi


Larutan jernih, steril, warna kuning pucat dalam 1 ml ampul amber.

Tiap ml injeksi berisi:
Phytomenadione ......................................... 2 mg

Vitamin Kl diperlukan untuk pembentukan faktor pembekuan darah dalam hati, seperti faktor II (prothrombin), VII, IX dan X. Vitamin Kl berperan sebagai ko-enzim pada karboksilasi rantai samping yang mengandung Asam Glutamat. Senyawa γ-karboksi glutamil yang dihasilkan akan mengubah prekursor menjadi faktor pembekuan aktif yang kemudian dikeluarkan oleh sel hati ke dalam darah.

Profilaksis dan pengobatan hemorrhage pada bayi yang baru lahir/ neonatus.

Dikontraindikasikan untuk penderita yang hipersensitif terhadap sediaan-sediaan sejenis.

Profilaksis hemorrhage pada bayi yang baru lahir:
0,5 - 1 mg Vitamin Kl diberikan secara i.m., 1 - 6 jam setelah bayi dilahirkan.
Pengobatan hemorrhage pada bayi yang baru lahir :
1 mg Vitamin Kl diberikan secara i.m./ s.k.

Pemberian secara intravena dapat menyebabkan sianosis, kolaps vaskular perifer, muka menjadi merah, berkeringat, rasa sakit pada dada, hiperhidrosis, shock dan hipersensitivitas atau reaksi tipe anafilaksis.
Reaksi yang serius dapat terjadi selama dan segera setelah pemberian secara intravena atau infus yang dapat berakibat fatal.
Pemberian secara intramuskular dapat menyebabkan rasa sakit pada tempat suntikan dan hemorrhage pada pasien hipoprotrombinemia.
Pemberian secara parenteral pada bayi yang baru lahir dapat meningkatkan "unbound plasma bilirubin" dan menyebabkan anemia hemolitik serta hemoglobinuria.

  • Efek koagulasi dari Vitamin Kl akan dihasilkan 1 - 2 jam setelah pemberian obat.
  • Tidak boleh melebihi dosis yang dianjurkan.
  • Vitamin Kl merupakan antagonis dari antikoagulan Kumarin namun tidak dapat menghambat kerja antikoagulan dari Heparin.
  • Vitamin Kl mudah terdegradasi oleh cahaya. Simpan sediaan ditempat yang terlindung dari cahaya.
  • Hindari penggunaan secara intravena.

Antikoagulan derivat kumarin mengadakan hambatan bersaing dengan vitamin Kl sehingga dapat menyebabkan hipoprotrombinemia dan perdarahan (hipoprotrombinemia berat).

Simpan dalam ruang ber-AC (suhu di bawah 25°C), terlindung dari cahaya dan kelembaban.

VITKA INFANT injeksi, dos, 10 ampul @ 1 ml
Reg. No. DKL 0919927043Al


Diproduksi oleh:
PT. Phapros Tbk.
Semarang, Indonesia
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Friday, November 27, 2015


Film Coated Tablet

Each film coated tablet contains 37.5 mg Tramadol hydrochloride and 325 mg Paracetamol.

Tramadol is an opioid analgesic that acts on the central nervous system. Tramadol is a pure non selective agonists of the m, d, and k opioid receptors with a higher affinity for the m receptors.
Other mechanisms which contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release. Tramadol has an antitussive effect. Unlike morphine, a broad range of analgesic doses of tramadol has no respiratory depressant effect.
Similarly, the gastro-intestinal motility is not modified. The cardiovascular effects are generally slight.
The potency of tramadol is considered to be one-tenth to one-sixth that of morphine.

Pharmacokinetic properties
Tramadol is administered in racemic form and the [-] and [+] forms of tramadol and its metabolite M1, are detected in the blood. Although tramadol is rapidly absorbed after administration, its absorption is slower (and its half-life longer) than that of paracetamol.
After a single oral administration of a tramadol/paracetamol (37.5 mg/325 mg) tablet, peak plasma concentrations of 64.3 (55.5 ng/ml [(+)-tramadol/(-)-tramadol] and 4.2 mg/ml (paracetamol) are reached after 1.8 h [(+)-tramadol/(-)-tramadol] and 0.9 h (paracetamol) respectively. The mean elimination half-lives 4 are 5.1/4.7 h [(+)-tramadol/(-)-tramadol] and 2,5 h (paracetamol).

Racemic tramadol is rapidly and almost completely absorbed after oral administration. The mean absolute bioavailability of a single 100 mg dose is approximately 75%. After repeated administration, the bioavailability is increased and reaches approximately 90%.
After administration, the oral absorption of paracetamol is rapid and nearly complete and takes place mainly in the small intestine. Peak plasma concentrations of paracetamol are reached in one hour and are not modified by concomitant administration of tramadol.
The oral administration with food has no significant effect on the peak plasma concentration or extent of absorption of either tramadol or paracetamol so that ACETRAM® can be taken independently of mealtimes.

Tramadol has a high tissue affinity (Vd,b = 203 401). It has a plasma protein binding of about 20%.
Paracetamol appears to be widely distributed throughout most body tissues except fat. Its apparent volume of distribution is about 0.9 L/kg. A relative small portion (~ 20%) of paracetamol is bound to plasma proteins.

Tramadol is extensively metabolised after oral administration. About 30 % of the dose is excreted in urine as unchanged drug, whereas 60% of the dose is excreted as metabolites.
Tramadol is metabolised through 0-demethylation (catalysed by the enzyme CYP2D6) to the metabolite M1, and through N-demethylation (catalysed by CYP3A) to the metabolite M2. M1 is further metabolized through N-demethylation and by conjugation with glucuronic acid. The plasma elimination half-life of M1 is 7 hours. The metabolite M1 has analgesic properties and is more potent than the parent drug. The plasma concentrations of M1 are several-fold lower than those of tramadol and the contribution to the clinical effect is unlikely to change on multiple dosing.
Paracetamol is principally metabolized in the liver through two major hepatic routes: glucuronidation and sulphation. The latter route can be rapidly saturated at doses above the therapeutic doses. A small fraction (less than 4%) is metabolised by cytochrome P 450 to an active intermediate (the N-acetyl benzoquinoneimine) which, under normal conditions of use, is rapidly detoxified by reduced glutathione and excreted in urine after conjugation to cysteine and mercapturic acid. However, during massive overdose, the quantity of this metabolite is increased.

Tramadol and its metabolites are eliminated mainly by the kidneys. The half-life of paracetamol is approximately 2 to 3 hours in adults. It is shorter in children and slightly longer in the newborn and in cirrhotic patients. Paracetamol is mainly eliminated by dose-dependent formation of glucuro- and sulpho-conjugate derivatives. Less than 9% of paracetamol is excreted unchanged in urine. In renal insufficiency, the half-life of both compounds is prolonged.

ACETRAM® is indicated for short term treatment of acute pain.
The use of ACETRAM® should be restricted to patients whose acute pain is considered to require a combination of tramadol and paracetamol (see also Pharmacological Properties).

ADULTS AND ADOLESCENTS (16 years and older)
The use of ACETRAM® should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol.
The dose should be individually adjusted according to intensity of pain and response of the patient.
An initial dose of two tablets of ACETRAM® is recommended. Additional doses can be taken as needed, notexceeding8tablets(equivalentto300mgtramadolarM 2600 mg paracetamol) per day.
The dosing interval should not be less than six hours.
ACETRAM® should under no circumstances be administered for longer than is strictly necessary see also Special warnings and precautions for use). If repeated use or long term treatment with ACETRAM® is required as a result of the nature and severity of the illness, then careful, regular monitoring should take place (with breaks in the treatment, where possible), to assess whether continuation of the treatment is necessary.

The effective and safe use of ACETRAM® has not been established in children below the age of 16 years. Treatment is therefore not recommended in this population.

The usual dosages may be used although it should be noted that in volunteers aged over 75 years the elimination half life of tramadol was increased by 17% following oral administration. In patients over 75 years old, it is recommended that the minimum interval between doses should be not less than 6 hours, due to the presence of tramadol.

Because of the presence of tramadol, the use of ACETRAM® is not recommended in patients with severe renal insufficiency (creatinine clearance ‹ 10 ml/min). In cases of moderate renal insufficiency (creatinine clearance between 10 and 30 ml/min), the dosing should be increased to 12-hourly intervals. As tramadol is removed only very slowly by haemodialysis or by haemofiltration, postdialysis administration to maintain analgesia is not usually required.

In patients with severe hepatic impairment ACETRAM® should not be used (see Contraindications).
In moderate cases prolongation of the dosage interval should be carefully considered (see Special Warnings and Precautions).

Method of administration
Oral use:
Tablets must be swallowed whole, with a sufficient quantity of liquid. They must not be broken or chewed.

  • Hypersensitivity to tramadol, paracetamol or to any of the excipients of the medicinal product, - Acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs, - ACETRAM® should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal (see 4.5. Interactions with other medicinal products and other forms of interaction),?
  • Severe hepatic impairment,
  • Epilepsy not controlled by treatment (see. Special Warnings and Precautions).

In adults and adolescents16 years and older. The maximum dose of 8 tablets of ACETRAM® should not be exceeded. In order to avoid inadvertent overdose, patients should be advised not to exceed the recommended dose and not to use any other paracetamol (including over the counter) or tramadol hydrochloride containing products concurrently without the advice of a physician.
In severe renal insufficiency (creatinine clearance ‹ 10 ml/mm), ACETRAM®is not recommended.
In patients with severe hepatic impairment ACETRAM® should not be used (See Contraindications).
The hazards of paracetamol overdose are greater in patients with non-cirrhotic alcoholic liver disease. In moderate cases prolongation of dosage interval should be carefully considered.
In severe respiratory insufficiency, ACETRAM® is not recommended. Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms. Convulsions have been reported in tramadol-treated patients susceptible to seizures or taking other medications that lower the seizure threshold, especially selective serotonin re-uptake inhibitors, tricyclic antidepressants, anti psychotics, centrally acting analgesics or local anaesthesia. Epileptic patients controlled by a treatment or patients susceptible to seizures should be treated with ACETRAM® only if there are compelling circumstances.
Convulsions have been reported in patients receiving tramadol at the recommended dose levels.
The risk may be increased when doses of tramadol exceed the recommended upper dose limit.
Concomitant use of opioid agonists-antagonists (nalbuphine, buprenorphine, pentazocine) is not recommended (see Drug Interactions).

Precautions for use:
ACETRAM® should be used with caution in opioid dependent patients, or in patients with cranial trauma, in patients prone to convulsive disorder, biliary tract disorders, in a state of shock, in an altered state of consciousness tor unknown reasons, with problems affecting the respiratory center or the respiratory function, or with an increased intracranial pressure.
Paracetamol in overdose may cause hepatic toxicity in some patients.
At therapeutic doses, tramadol has the potential to cause withdrawal symptoms. Rarely, cases of dependence and abuse have been reported.
Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms.
In one study, use of tramadol during general anaesthesia with enflurane and nitrous oxide was reported to enhance intra-operative recall. Until further information is available, use of tramadol during light planes of anaesthesia should be avoided.

Concomitant use is contraindicated with:
-Non-selective MAO Inhibitors
Risk of serotoninergic syndrome: diarrhoea, tachycardia, sweating, trembling, confusion, even coma.
-Selective-A MAO Inhibitors
Extrapolation from non-selective MAO inhibitors
Risk of serotoninergic syndrome: diarrhoea, tachycardia, sweating, trembling, confusion, even coma.
-Selective-B MAO Inhibitors
Central excitation symptoms evocative of a serotoninergic syndrome: diarrhoea, tachycardia, sweating, trembling, confusion, even coma.

In case of recent treatment with MAO inhibitors, a delay of two weeks should occur before treatment with tramadol.

Concomitant use is not recommended with:
Alcohol increases the sedative effect of opioid analgesics.
The effect on alertness can make driving of vehicles and the use of machines dangerous.
Avoid intake of alcoholic drinks and of medicinal products containing alcohol.
-Carbamazepine and other enzyme inducers
Risk of reduced efficacy and shorter duration due to decreased plasma concentrations of tramadol.
-Opioid agonists-antagonists (buprenorphine, nalbuphine, pentazocine)
Decrease of the analgesic effect by competitive blocking effect at the receptors, with the risk of occurrence of withdrawal syndrome.

Concomitant use which needs to be taken Into consideration:
  • In isolated cases there have been reports of Serotonin Syndrome in a temporal connection with the therapeutic use of tramadol in combination with other serotoninergic medicines such as selective serotonin re-uptake inhibitors (SSRIs) and triptans. Signs of Serotonin Syndrome may be for example, confusion, agitation, fever, sweating, ataxia, hyperreflexia, myoclonus and diarrhoea.
  • Other opioid derivatives (including antitussive drugs and substitutive treatments), benzodiazepines and barbiturates, increased risk of respiratory depression which can be fatal in cases of overdose.
  • Other central nervous system depressants, such as other opioid derivatives (including antitussive drugs and substitute treatments), barbiturates, benzodiazepines, other anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, neuroleptics, centrally-acting antihypertensive drugs, thalidomide and baclofen. These drugs can cause increased central depression. The effect on alertness can make driving of vehicles and the use of machines dangerous.
  • As medically appropriate, periodic evaluation of prothrombin time should be performed when ACETRAM® and warfarin like compounds are administered concurrently due to reports of increased INR.
  • Other drugs known to Inhibit CYP3A4, such as ketoconazole and erythromycin, might inhibit the metabolism of tramadol (N-demethylation) probably also the metabolism of the active 0-demethylated metabolite. The clinical importance of such an interaction has not been studied.
Medicinal products reducing the seizure threshold, such as bupropion, serotonin reuptake inhibitor antidepressants, tricyclic antidepressants and neuroleptics. Concomitant use of tramadol with these drugs can increase the risk of convulsions. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

Pregnancy and lactation
Since ACETRAM® is a fixed combination of active ingredients including tramadol, it should not be used during pregnancy
-Data regarding paracetamol:
Epide miological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosages.
-Data regarding tramadol:
Tramadol should not be used during pregnancy as there is inadequate evidence available to assess the safety of tramadol in pregnant women. Tramadol administered before or during birth does not affect uterine contractility. In neonates it may induce changes in the respiratory rate which are usually not clinically relevant.

Since ACETRAM® is a fixed combination of active ingredients including tramadol, it should not be ingested during breastfeeding.
-Data regarding paracetamol
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding by women using single ingredient medicinal products containing only paracetamol.
-Data regarding tramadol
Tramadol and its metabolites are found in small amounts in human breast milk. An infant could ingest about 0.1% of the dose given to the mother. Tramadol should not be ingested during breast feeding.

Effects on ability to drive and use machines:
Tramadol may cause drowsiness or dizziness, which may be enhanced by alcohol or other CNS
depressants. If affected, the patient should not drive or operate machinery.

The most commonly reported undesirable effects during the clinical trials performed with the
paracetamol/tramadol combination were nausea, dizziness and somnolence, observed in more
than 10% of the patients.
Cardiovascular system disorders:
-Uncommon (0.1% -1%):hypertension, palpitations, tachycardia, arrythmia.

Central and peripheral nervous system disorders:
-Very common (› 10%):dizziness, somnolence
-Common (1%-10%):headache trembling
-Uncommon (0.1%-1%):involuntary muscularcontractions, paresthesia, tinnitus
-Rare (‹ 0.1%):ataxia, convulsions.

Psychiatric disorders:
-Common (1% -10%):confusion, mood changes (anxiety, nervousness, euphoria), sleep disorders
-Uncommon (0.1%-1%):depression, hallucinations, nightmares, amnesia
-Rare (‹0.1%):drug dependence.

Vision disorders:
-Rare (0.1%):blurred vision

Respiratory system disorders:
-Uncommon (0.1%-1%):dyspnoea

Gastro-intestinal disorders:
-Very common (›10%):nausea
-Common (1% -10%):vomiting, constipation, dry mouth, diarrhoea abdominal pain,
dyspepsia, flatulence
-Uncommon (0.1 %-1%):dysphagia. melaena.

Liver and biliary system disorders
-Uncommon (0.1%-1%):hepatic transaminases increase

Skin and appendages disorders:
-Common (1%-10%):sweating, pruritus
-Uncommon (0.1 %-1%):dermal reactions (e.g. rash, urticaria).

Urinary system disorders:
-Uncommon (0.1%-1%):albuminuria, micturition disorders (dysuria and urinary retention).

Body as a whole:
-Uncommon (0.1%-1%):shivers, hot flushes, thoracic pain.

-Although not observed during clinical trials, the occurrence of the following undesirable effects known to be related to the administration of tramadol or paracetamol cannot be excluded:


  • Postural hypotension, bradycardia, collapse (tramadol).
  • Post-marketing surveillance of tramadol has revealed rare alterations of warfarin effect, including elevation of prothrombin times.
  • Rare cases (‹ 0.1%): allergic reactions with respiratory symptoms (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis
  • Rare cases (‹ 0.1 %): changes in appetite, motor weakness, and respiratory depression
  • Psychic side-effects may occur following administration of tramadol which vary individually in intensity and nature (depending on personality and duration of medication). These include changes in mood, (usually elation occasionally dysphoria), changes in activity (usually suppression occasionally increase) and changes in cognitive and sensorial capacity (e.g. decision behaviour perception disorders).
  • Worsening of asthma has been reported though a causal relationship has not been established.
  • Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms.


  • Adverse effects of paracetamol.are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
  • There have been several reports that suggest that paracetamol may produce hypoprothrombinemia when administered with warfarin-like compounds. In other studies, prothrombin time did not change.

Acetram is a fixed combination of active ingredients. In case of overdose, the symptoms may include
the signs and symptoms of toxicity of tramadol or paracetamol or of both these active ingredients.

Symptoms of overdose from tramadol:
In principle, on intoxication with tramadol, symptoms similar to those of other centrally acting
analgesics (opioids) are to be expected. These include in particular, miosis, vomiting, cardiovascular
collapse, consciousness: disorders up to coma, convulsions and respiratory depression up to
respiratory arrest.

Symptoms of overdose from paracetamol:
An overdose is of particular concern in young children. Symptoms of paracetamol overdose in the
first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become
apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis
may occur. In severe poisoning, hepatic failure may progress to encephalophathy, coma and death.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver
damage. Cardiac arrhythmias and pancreatitis have been reported.
Liver damage is possible in adults who have taken 7.5-10 g or more of paracetamol. It is considered
that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when
normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Emergencv treatment:

  • Transfer immediately to a specialised unit.
  • Maintain respiratory and circulatory functions
  • Prior to starting treatment, a blood sample should be taken as soon as possible after overdose in order to measure the plasma concentration of paracetamol and tramadol and in order to perform hepatic tests.
  • Perform hepatic tests at the start (of overdose) and repeat every 24 hours An increase in hepatic enzymes (ASAT, ALAT) is usually observed, which normalizes after one or two weeks.
  • Empty the stomach by causing the patient to vomit (when the patient Is conscious) by irritation or gastric lavage.
  • Supportive measures such as maintaining the potency of the airway and maintaining cardiovascular function should be instituted; naloxone should be used to reverse respiratory depression; fits can be controlled with diazepam.
  • Tramadol is minimally eliminated from the serum by haemodialysis or haemofiltrafon. Therefore treatment of acute intoxication with ACETRAM® with haemodialysis or haemofiltration alone is not suitable for detoxification.

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any adult or adolescent who had ingested around 7.5 g or more of paracetamol in the preceding 4 hours or any child who has ingested 150 mg/kg of paracetamol in the preceding 4 hours should undergo gastric lavage. Paracetamol concentrations in blood should be measured later than 4 hours after overdose in order to be able to assess the risk of developing liver damage (via the paracetamol overdose nomogram). Administration of oral methionine or intravenous N-acetylcysteine (NAC) which may have a beneficial effect up to at least 48 hours after the overdose, may be required. Administration of intravenous NAC is most beneficial when initiated within 8 hours of overdose ingestion. However, NAC should still be given if the time to presentation is greater than 8 hours after overdose and continued for a full course of therapy. NAC treatment should be started immediately when massive overdose is suspected. General supportive measures must be available.
Irrespective of the reported quantity of paracetamol ingested, the antidote for paracetamol, NAC, should be administered orally or intravenously, as quickly as possible. If possible, within 8 hours following the overdose.

Store in dry place below 25°C

ACETRAM® Film Coated Tablet
Box, 1 blister @ 10 film coated tablets
Reg. No. DKL1040400117A1


Manufactured by:
Jakarta - Indonesia

Tangerang - Indonesia
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