Rompun

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Rompun uses



Rompun

(xylazine) 100 mg/mL Injection

SEDATIVE AND ANALGESIC FOR USE IN HORSES AND CERVIDAE ONLY


NOT FOR HUMAN USE

KEEP OUT OF REACH OF CHILDREN


CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Do not use in Cervidae less than 15 days before, or during the hunting season.


DESCRIPTION

Rompun (xylazine) is supplied in 50 ml multiple-dose vials as a sterile solution. Each mL contains 100 mg Rompun (xylazine base equivalent); 0.9 mg methylparaben; 0.1 mg propylparaben; water for injection; citric acid and sodium citrate for pH adjustment to 5.5 ± 0.3.


ACTIVE INGREDIENT:

Rompun hydrochloride... 11.7%

(Equivalent to 10% base)

INERT INGREDIENTS:... 88.3%

100.0%




PHARMACOLOGY

Rompun a non-narcotic compound, is a sedative and analgesic as well as muscle relaxant. Its sedative and analgesic activity is related to central nervous system depression. Its muscle-relaxant effect is based on inhibition of the intraneural transmission of impulses in the central nervous system. The principal pharmacological activities develop within 10 to 15 minutes after intramuscular injection, and within 3 to 5 minutes following intravenous administration in horses.

A sleeplike state, the depth of which is dose-dependent, is usually maintained for 1 to 2 hours, while analgesia lasts from 15 to 30 minutes. The centrally acting muscle relaxant effect causes relaxation of the skeletal musculature, complementing sedation and analgesia.

In horses and Cervidae under the influence of Rompun the respiratory rate is reduced as in natural sleep. Following treatment with Rompun the heart rate is decreased and a transient change in the conductivity of the cardiac muscle may occur, as evidenced by a partial atrioventricular block. This resembles the atrioventricular block often observed in normal horses. 1, 2, 3, 4

Although a partial A-V block may occasionally occur following intramuscular injection of Rompun, the incidence is less than when it is administered intravenously. Intravenous administration of Rompun causes a transient rise in blood pressure, followed by a slight decrease.

Rompun has no effect on blood clotting time or other hematologic parameters.

INDICATIONS


Rompun should be used in horses and Cervidae (Fallow Deer, Mule Deer, Sika Deer, White-Tailed Deer, and Elk) when it is desirable to produce a state of sedation accompanied by a shorter period of analgesia.

Horses: Rompun has been used successfully as follows:

1. Diagnostic procedures-oral and ophthalmic examinations, abdominal palpation, rectal palpation, vaginal examination, catheterization of the bladder and radiographic examinations.

2. Orthopedic procedures, such as application of casting materials and splints.

3. Dental procedures.

4. Minor surgical procedures of short duration such as debridement, removal of cutaneous neoplasms and suturing of lacerations.

5. To calm and facilitate handling of fractious animals.

6. Therapeutic medication for sedation and relief of pain following injury or surgery.

7. Major surgical procedures:

a. When used as a preanesthetic to general anesthesia.

b. When used in conjunction with local anesthetics.

Cervidae : Rompun may be used for the following:

1. To calm and facilitate handling of fractious animals.

2. Diagnostic procedures.

3. Minor surgical procedures.

4. Therapeutic medication for sedation and relief of pain following injury or surgery.

5. As a preanesthetic to local anesthesia.

Rompun at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine.


DOSAGE AND ADMINISTRATION

Horses:

1. Dosage:

lntravenously-0.5 mL/100 lbs body weight (0.5 mg/lb)

lntramuscularly-1.0 mL/100 lbs body weight (1.0 mg/lb)

Following injection of Rompun, the animal should be allowed to rest quietly until the full effect has been reached.

These dosages produce sedation which is usually maintained for 1 to 2 hours, and analgesia which lasts for 15 to 30 minutes.

2. Preanesthetic to Local Anesthesia:

Rompun at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine.

3. Preanesthetic to General Anesthesia:

Rompun at the recommended dosage rates, produces an additive effect to central nervous system depressants such as pentobarbital sodium, thiopental sodium and thiamylal sodium. Therefore, the dosage of such compounds should be reduced and administered to the desired effect. In general, only 1/3 to 1/2 of the calculated dosage of the barbiturates will be needed to produce a surgical plane of anesthesia. Post-anesthetic or emergence excitement has not been observed in animals preanesthetized with Rompun.

Rompun has been used successfully as a preanesthetic agent for pentobarbital sodium, thiopental sodium, thiamylal sodium, nitrous oxide, ether, halothane, glyceryl guaiacolate and methoxyflurane anesthesia.


Cervidae :

Administer intramuscularly, by either hand syringe or syringe dart, in the heavy muscles of the croup or shoulder.

Dosage Range:

Fallow Deer (Dama dama)-2.0 to 4.0 mL/100 lbs body weight (2.0 to 4.0 mg/lb).

Mule Deer (Odocoileus hemionus)-1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb).

Sika Deer (Cervus nippon)-1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb).

White-Tailed Deer (Odocoileus virginianus)-1.0to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb).

Elk (Cervus canadensis)-0.25 to 0.5 mL/100 lbs body weight (0.25 to 0.5 mg/lb).


Following injection of Rompun the animal should be allowed to rest quietly until the full effect has been reached.


These dosages produce sedation which is usually maintained for 1 to 2 hours and analgesia which lasts for 15 to 30 minutes.



SIDE EFFECTS

Rompun, in horses and Cervidae, used at recommended dosage levels may occasionally cause slight muscle tremors, bradycardia with partial A-V heart block and a reduced respiratory rate. Movement in response to sharp auditory stimuli may be observed. In horses, sweating, rarely profuse, has been reported following administration. In Cervidae, salivation, various vocalizations (bellowing, bleating, groaning, grunting, snoring) on expiration, audible grinding of molar teeth, protruding tongue, and elevated temperatures have been noted in some cases.


PRECAUTlONS

Careful consideration should be given before administering to horses or Cervidae, with significantly depressed respiration, severe pathologic heart disease, advanced liver or kidney disease, severe endotoxic or traumatic shock, or stress conditions such as extreme heat, cold, high altitude or fatigue.

Do not use Rompun in conjunction with tranquilizers.

Analgesic effect is variable, and depth should be carefully assayed prior to surgical/clinical procedures. Variability of analgesia occurs most frequently at the distal extremities of horses and Cervidae. In spite of sedation, the practitioner and handlers should proceed with caution since defense reactions may not be diminished.

Horses:

Since an additive effect results from the use of Rompun and the barbiturate compounds, it should be used with caution with these central nervous system depressants. Products known to produce respiratory depression or apnea, such as thiamylal sodium, should be given at a reduced dosage and, when injected intravenously, should be administered slowly. When intravenous administration is desired, avoid perivascular injection in order to achieve the desired effect. Studies have shown negligible evidence of tissue irritation, however, following perivascular injection of Rompun.

lntracarotid Arterial Injection Should Be Avoided. As with many compounds, including tranquilizers, immediate violent seizures followed by collapse may result from inadvertent administration into the carotid artery. Although the reaction with Rompun is usually transient and recovery may be rapid and complete, special care should be taken to assure that the needle is in the jugular vein rather than the carotid artery.

Bradycardia and an arrhythmia in the form of incomplete atrioventricular block have been reported following Rompun administration. Although clinically the importance of this effect is questioned,1,2,3,4 a standard dose of atropine given prior to or following Rompun will greatly decrease the incidence.

Sedation for transport is most successful if actual transportation is begun after the full effect of the drug has been reached and the animal's stability is maintained while standing. In addition, it should be noted that animals under the influence of Rompun can be aroused by noise or other stimuli and this may increase the risk of injury.

Cervidae:

As in all ruminants, it is preferable to administer Rompun to fasted Cervidae as a safeguard against aspiration of food material into the lungs and/or bloat during deep sedation.

Care should be taken to administer Rompun in the heavy muscles of the croup or shoulder. Injections given subcutaneously, intraperitoneally or into fat deposits will give unpredictable results.

Intra-arterial injection should be avoided. As with many compounds, including tranquilizers, immediate violent seizures followed by collapse may result from inadvertent administration into an artery.

The animal should not be disturbed during induction or until the full effect of the drug has been reached, which is usually 10 to 15 minutes following injection.

The usual time to initial effect of the drug is 2 to 5 minutes. The administrator of the drug should be fully cognizant of this interval prior to administration of drug to free ranging deer or elk, especially at night or in heavily wooded areas.

If the animal has been underdosed (faulty injection or miscalculation of weight) it is advisable to wait one hour before administering a second dose.

Adequate ventilation, especially in cages or crates, is mandatory; keep head and neck in position to insure patent air passage and to prevent aspiration of stomach contents.

During sedation animals should be prevented from assuming lateral recumbency. A sternal recumbent position is desirable.

While under the effects of Rompun the animal should be protected from an extremely hot or cold environment.

Efforts should be made to prevent patient from rising until almost complete recovery is attained.

The transportation of Cervidae given Rompun should be carefully monitored to prevent excessive struggling, injury or death.

Hyperthermic reactions may occur, especially if the subject is in a highly excited state when the drug is administered. Hosing the head and entire body with cold water has usually proven to be an effective deterrent.

The safety of Rompun has not been demonstrated in pregnant Cervidae. Avoid use during the breeding season.

Cervidae should be observed closely until all of the sedative effects of Rompun are gone.

Care should be taken at all times when administering Rompun to Cervidae. This is due to the method of administration (usually darting), the difficulty in estimating body weights and the accepted theory that wild animals are more unpredictable in their response to sedatives and analgesics than the domesticated species.

SAFETY

Rompun is tolerated at 10 times the recommended dose in horses, and at doses above the recommended range in Cervidae. However, some elevated doses produced muscle tremors and long periods of sedation.

WARNING

This drug should not be administered to domestic food-producing animals. Not for use in horses intended for food.

Avoid accidental administration to humans. Should such exposure occur, notify a physician immediately. Artificial respiration may be indicated.

In Cervidae, occasional capture-associated deaths occur. Clinical trials reveal a mortality rate of approximately 3.5% attendant with the administration of Rompun.

HOW SUPPLIED

Rompun 100 mg/ml Injection for intravenous or intramuscular use is available in 50 mL multiple dose vials.

STORAGE

Store at 20°C- 25°C (68°F to 77°F). Do not freeze.

REFERENCES


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Rompun 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.


Rompun 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.


Rompun 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.


Rompun 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.


Rompun 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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References

  1. Dailymed."ANASED (XYLAZINE HYDROCHLORIDE) INJECTION, SOLUTION [AKORN ANIMAL HEALTH, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Rompun?

Depending on the reaction of the Rompun after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Rompun 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 Rompun 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 Rompun, 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 Rompun 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. Rachana Salvi, MD Pharmacology

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