Capricyn

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Capricyn uses


INDICATIONS AND USAGE

Capricyn, which is to be used concomitantly with other appropriate antituberculosis agents, is indicated in pulmonary infections caused by capreomycin-susceptible strains of M. tuberculosis when the primary agents (isoniazid, rifampin, ethambutol, aminosalicylic acid, and streptomycin) have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli.

Susceptibility studies should be performed to determine the presence of a capreomycin-susceptible strain of M. tuberculosis.

CONTRAINDICATION

Capricyn is contraindicated in patients who are hypersensitive to Capricyn.

PRECAUTIONS

General

Audiometric measurements and assessment of vestibular function should be performed prior to initiation of therapy with Capricyn and at regular intervals during treatment.

Renal injury, with tubular necrosis, elevation of the blood urea nitrogen or serum creatinine, and abnormal urinary sediment, has been noted. Slight elevation of the BUN and serum creatinine has been observed in a significant number of patients receiving prolonged therapy. The appearance of casts, red cells, and white cells in the urine has been noted in a high percentage of these cases. Elevation of the BUN above 30 mg/100 mL or any other evidence of decreasing renal function with or without a rise in BUN levels calls for careful evaluation of the patient, and the dosage should be reduced or the drug completely withdrawn. The clinical significance of abnormal urine sediment and slight elevation in the BUN (or serum creatinine) observed during long-term therapy with Capricyn has not been established.

The peripheral neuromuscular blocking action that has been attributed to other polypeptide antibiotics (colistin sulfate, polymyxin A sulfate, paromomycin, and viomycin) and to aminoglycoside antibiotics (streptomycin, dihydrostreptomycin, neomycin, and kanamycin) has been studied with Capricyn. A partial neuromuscular blockade was demonstrated after large intravenous doses of Capricyn. This action was enhanced by ether anesthesia (as has been reported for neomycin) and was antagonized by neostigmine.

Caution should be exercised in the administration of antibiotics, including Capricyn, to any patient who has demonstrated some form of allergy, particularly to drugs.

Laboratory Tests

Regular tests of renal function should be made throughout the period of treatment, and reduced dosage should be employed in patients with known or suspected renal impairment.

Renal function studies should be made both before therapy with Capricyn is started and on a weekly basis during treatment.

Since hypokalemia, hypomagnesemia and hypocalcemia may occur during therapy, these serum electrolyte levels should be determined frequently.

Drug Interactions

For neuromuscular blocking action of this drug, see PRECAUTIONS, GENERAL.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed to determine potential for carcinogenicity, mutagenicity, or impairment of fertility.

Usage in Pregnancy - Pregnancy Category C

Capricyn has been shown to be teratogenic in rats when given in doses 3 1/2 times the human dose. There are no adequate and well-controlled studies in pregnant women. Capricyn should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Capricyn is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Capricyn did not analyze the safety and efficacy of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Capricyn is known to be substantially excreted by the kidney (see CLINICAL PHARMACOLOGY), and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS, Laboratory Tests). Patients with reduced renal function should have dosage reduction based on creatinine clearance using the guidelines included in Table 1 (see DOSAGE AND ADMINISTRATION).

The geriatric population is also more likely to have impaired hearing at baseline. Audiometric measurements and assessment of vestibular function should be performed prior to initiation of therapy with Capricyn and at regular intervals during treatment (see PRECAUTIONS, General).

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ADVERSE REACTIONS

Nephrotoxicity: In 36% of 722 patients treated with Capricyn, elevation of the BUN above 20 mg/100 mL has been observed. In many instances, there was also depression of PSP excretion and abnormal urine sediment. In 10% of this series, the BUN elevation exceeded 30 mg/100 mL.

Toxic nephritis was reported in 1 patient with tuberculosis and portal cirrhosis who was treated with Capricyn (1 g) and aminosalicylic acid daily for 1 month. This patient developed renal insufficiency and oliguria and died. Autopsy showed subsiding acute tubular necrosis.

Electrolyte disturbances including hypokalemia, hypomagnesemia and hypocalcemia, sometimes serious in nature, have been reported.

Ototoxicity: Subclinical auditory loss was noted in approximately 11% of 722 patients undergoing treatment with Capricyn. This was a 5- to 10-decibel loss in the 4000- to 8000-CPS range. Clinically apparent hearing loss occurred in 3% of the 722 subjects. Some audiometric changes were reversible. Other cases with permanent loss were not progressive following withdrawal of Capricyn.

Tinnitus and vertigo have occurred.

Liver: Serial tests of liver function have demonstrated a decrease in BSP excretion without change in AST (SGOT) or ALT (SGPT) in the presence of preexisting liver disease. Abnormal results in liver function tests have occurred in many persons receiving Capricyn in combination with other antituberculosis agents that also are known to cause changes in hepatic function. The role of Capricyn in producing these abnormalities is not clear; however, periodic determinations of liver function are recommended.

Blood: Leukocytosis and leukopenia have been observed. The majority of patients treated have had eosinophilia exceeding 5% while receiving daily injections of Capricyn. This has subsided with reduction of the Capricyn dosage to 2 or 3 g weekly.

Pain and induration at the injection site have been observed. Excessive bleeding at the injection site has been reported. Sterile abscesses have been noted. Rare cases of thrombocytopenia have been reported.

Hypersensitivity: Urticaria and maculopapular skin rashes associated in some cases with febrile reactions have been reported when Capricyn and other antituberculosis drugs were given concomitantly.

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OVERDOSAGE

Signs and Symptoms

Nephrotoxicity following the parenteral administration of Capricyn is most closely related to the area under the curve of the serum concentration versus time graph. The elderly patient, patients with abnormal renal function or dehydration, and patients receiving other nephrotoxic drugs are at much greater risk for developing acute tubular necrosis.

Damage to the auditory and vestibular divisions of cranial nerve VIII has been associated with Capricyn given to patients with abnormal renal function or dehydration and in those receiving medications with additive auditory toxicities. These patients often experience dizziness, tinnitus, vertigo, and a loss of high-tone acuity.

Neuromuscular blockage or respiratory paralysis may occur following rapid intravenous infusion.

If Capricyn is ingested, toxicity would be unlikely because it is poorly absorbed from an intact gastrointestinal system.

Hypokalemia, hypocalcemia, hypomagnesemia, and an electrolyte disturbance resembling Bartter's syndrome have been reported to occur in patients with Capricyn toxicity.

The subcutaneous median lethal dose in mice was 514 mg/kg.

Treatment

To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.

Patients who have received an overdose of Capricyn and have normal renal function should be carefully hydrated to maintain a urine output of 3 to 5 mL/kg/h. Fluid balance, electrolytes, and creatinine clearance should be carefully monitored.

Hemodialysis may be effectively used to remove Capricyn in patients with significant renal disease.

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DOSAGE AND ADMINISTRATION

Capricyn may be administered intramuscularly or intravenously following reconstitution. Reconstitution is achieved by dissolving the vial contents (1 g) in 2 mL of 0.9% Sodium Chloride Injection or Sterile Water for Injection. Two to 3 minutes should be allowed for complete dissolution.

Intravenously - For intravenous infusion, reconstituted Capricyn should be diluted in 100 mL of 0.9% Sodium Chloride Injection and administered over 60 minutes.

Intramuscularly - Reconstituted Capricyn should be given by deep intramuscular injection into a large muscle mass, since superficial injection may be associated with increased pain and the development of sterile abscesses.

For administration of a 1-g dose, the entire contents of the vial should be given. For doses lower than 1 g, the following dilution table may be used.

* Equivalent to Capricyn activity. Approximated concentration takes into account the retention volume.

DILUTION TABLE
Diluent Added to

1-g, 10-mL Vial

Volume of Capastat

Sulfate Solution

Concentration

(Approx)

2.15 mL 2.85 mL 370 mg*/mL
2.63 mL 3.33 mL 315 mg*/mL
3.3 mL 4 mL 260 mg*/mL
4.3 mL 5 mL 210 mg*/mL

The solution may acquire a pale straw color and darken with time, but this is not associated with loss of potency or the development of toxicity. After reconstitution, all solutions of Capricyn may be stored for up to 24 hours under refrigeration.

Capricyn is always administered in combination with at least 1 other antituberculosis agent to which the patient's strain of tubercle bacilli is susceptible. The usual dose is 1 g daily (not to exceed 20 mg/kg/day) given intramuscularly or intravenously for 60 to 120 days, followed by 1 g by either route 2 or 3 times weekly. (Note - Therapy for tuberculosis should be maintained for 12 to 24 months. If facilities for administering injectable medication are not available, a change to appropriate oral therapy is indicated on the patient's release from the hospital.)

Patients with reduced renal function should have dosage reduction based on creatinine clearance using the guidelines included in Table 1. These dosages are designed to achieve a mean steady-state Capricyn level of 10 μg/mL.

a For patients with renal impairment, initial maintenance dose estimates are given for optional dosing intervals; longer dosing intervals are expected to provide greater peak and lower trough serum Capricyn levels than shorter dosing intervals.

b The usual dosage for patients with normal renal function is 1000 mg daily, not to exceed 20 mg/kg/day, for 60 to 120 days, then 1000 mg 2 to 3 times weekly.

Capricyn Dosea (mg/kg) for the Following
CrCl Clearance Half-life Dosing Intervals
(mL/min) (L/kg/h x 10-2) (hours) 24 h 48 h 72 h
0 0.54 55.5 1.29 2.58 3.87
10 1.01 29.4 2.43 4.87 7.30
20 1.49 20.0 3.58 7.16 10.7
30 1.97 15.1 4.72 9.45 14.2
40 2.45 12.2 5.87 11.7
50 2.92 10.2 7.01 14.0
60 3.40 8.8 8.16
80 4.35 6.8 10.4b
100 5.31 5.6 12.7b
110 5.78 5.2 13.9b

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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HOW SUPPLIED

Capastat® Sulfate, Capricyn for Injection, USP, is available in:

Vials: 1 g*, 10 mL size (No. 718) (1s) NDC 17478-080-50

___________

*Equivalent to Capricyn activity.

Store at controlled room temperature 15° to 30°C (59° to 86°F) prior to reconstitution.

ANIMAL PHARMACOLOGY

In addition to renal and cranial nerve VIII toxicity demonstrated in animal toxicology studies, cataracts developed in 2 dogs on doses of 62 mg/kg and 100 mg/kg for prolonged periods.

In teratology studies, a low incidence of “wavy ribs” was noted in litters of female rats treated with daily doses of 50 mg/kg or more of Capricyn.

REFERENCES

  • Lehmann CR, Garrett LE, Winn RE, Springberg PD, Vicks S, Porter DK, Pierson WP, Wolny JD, Brier GL, Black HR. Capricyn kinetics in renal impairment and clearance by hemodialysis. Am Rev Respir Dis 1988;138/5:1312-3.
  • Unpublished data on file at Akorn.

Manufactured by: Akorn, Inc.

Lake Forest, IL 60045

CT00N Rev. 09/09

CAPASTAT ® SULFATE Container Label Principal Display Panel Text:

1 VIAL NDC 17478-080-50

CAPASTAT® SULFATE

Capricyn FOR

INJECTION, USP

Equivalent to

1 g

Capricyn Activity

Rx only

CAPASTAT ® SULFATE Carton Label Principal Display Panel Text:

CAPASTAT®

SULFATE

Capricyn FOR

INJECTION, USP

Equivalent to

1 g

Capricyn Activity

FOR INTRAMUSCULAR

AND INTRAVENOUS

INFUSION ONLY

Rx only

Capricyn pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Capricyn available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Capricyn destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Capricyn Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Capricyn pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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Frequently asked Questions

Can i drive or operate heavy machine after consuming Capricyn?

Depending on the reaction of the Capricyn after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Capricyn not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Capricyn addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Capricyn, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Capricyn consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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