DRUGS & SUPPLEMENTS
INDICATIONS AND USAGE:
Central Diabetes Insipidus:
Desmopressin tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin tablets are ineffective for the treatment of nephrogenic diabetes insipidus.
Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to Desmopressin can be monitored by measuring urine volume and osmolality.
Primary Nocturnal Enuresis:
Desmopressin tablets are indicated for the management of primary nocturnal enuresis. Desmopressin tablets may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention.
Desmopressin tablets are contraindicated in individuals with known hypersensitivity to Desmopressin or to any of the components of Desmopressin tablets.
Desmopressin is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).
Desmopressin is contraindicated in patients with hyponatremia or a history of hyponatremia.
Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with Desmopressin. Desmopressin is a potent antidiuretic which, when administered, may lead to water intoxication and/or hyponatremia. Unless properly diagnosed and treated hyponatremia can be fatal. Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. Careful medical supervision is required.
When Desmopressin tablets are administered, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward to decrease the potential occurrence of water intoxication and hyponatremia. (See PRECAUTIONS, Pediatric Use and Geriatric Use.) All patients receiving Desmopressin therapy should be observed for the following signs of symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. Severe symptoms may include one or a combination of the following: seizure, coma and/or respiratory arrest. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures which could lead to coma.
Desmopressin should be used with caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, putting them at greater risk of hyponatremia.
Intranasal formulations of Desmopressin at high doses and Desmopressin injection have infrequently produced a slight elevation of blood pressure which disappears with a reduction of dosage. Although this effect has not been observed when single oral doses up to 0.6 mg have been administered, the drug should be used with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease, because of a possible rise in blood pressure.
Desmopressin should be used with caution in patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, since these patients may develop hyponatremia.
Rare severe allergic reactions have been reported with Desmopressin. Anaphylaxis has been reported with intravenous and intranasal administration of Desmopressin, but not with Desmopressin tablets.
Central Diabetes Insipidus: Laboratory tests for monitoring the patient with central diabetes insipidus or post-surgical or head trauma-related polyuria and polydipsia include urine volume and osmolality. In some cases, measurements of plasma osmolality may be useful.
Although the pressor activity of Desmopressin is very low compared to its antidiuretic activity, large doses of Desmopressin tablets should be used with other pressor agents only with careful patient monitoring.
Carcinogenicity, Mutagenicity, and Impairment of Fertility:
Studies with Desmopressin have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
Fertility studies have not been done. Teratology studies in rats and rabbits at doses from 0.05 to 10 µg/kg/day revealed no harm to the fetus due to Desmopressin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Several publications where Desmopressin was used in the management of diabetes insipidus during pregnancy are available; these include a few anecdotal reports of congenital anomalies and low birth weight babies. However, no causal connection between these events and Desmopressin has been established. A fifteen year Swedish epidemiologic study of the use of Desmopressin in pregnant women with diabetes insipidus found the rate of birth defects to be no greater than that in the general population; however, the statistical power of this study is low. As opposed to preparations containing natural hormones, Desmopressin in antidiuretic doses has no uterotonic action and the physician will have to weigh the possible therapeutic advantages against the possible risks in each case.
There have been no controlled studies in nursing mothers. A single study in postpartum women demonstrated a marked change in plasma, but little if any change in assayable Desmopressin in breast milk following an intranasal dose of 0.01 mg.
It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Desmopressin is administered to nursing mothers.
Central Diabetes Insipidus: Desmopressin tablets have been used safely in pediatric patients, age 4 years and older, with diabetes insipidus for periods up to 44 months. In younger pediatric patients the dose must be individually adjusted in order to prevent an excessive decrease in plasma osmolality leading to hyponatremia and possible convulsions; dosing should start at 0.05 mg (1/2 of the 0.1 mg tablet). Use of Desmopressin in pediatric patients requires careful fluid intake restrictions to prevent possible hyponatremia and water intoxication.
Primary Nocturnal Enuresis: Desmopressin tablets have been safely used in pediatric patients age 6 years and older with primary nocturnal enuresis for up to 6 months. Some patients respond to a dose of 0.2 mg; however, increasing responses are seen at doses of 0.4 mg and 0.6 mg. No increase in the frequency or severity of adverse reactions or decrease in efficacy was seen with an increased dose or duration. The dose should be individually adjusted to achieve the best results.
Infrequently, large doses of the intranasal formulations of Desmopressin and Desmopressin injection have produced transient headache, nausea, flushing and mild abdominal cramps. These symptoms have disappeared with reduction in dosage.
Central Diabetes Insipidus:
In long-term clinical studies in which patients with diabetes insipidus were followed for periods up to 44 months of Desmopressin tablet therapy, transient increases in AST no higher than 1.5 times the upper limit of normal were occasionally observed. Elevated AST (SGOT) returned to the normal range despite continued use of Desmopressin tablets.
Primary Nocturnal Enuresis:
The only adverse event occurring in ≥ 3% of patients in controlled clinical trials with Desmopressin tablets that was probably, possibly, or remotely related to study drug was headache (4% Desmopressin, 3% placebo).
The following adverse events have been reported; however, their relationship to Desmopressin has not been established: abnormal thinking, diarrhea, and edema-weight gain.
(See ADVERSE REACTIONS.) In case of overdose, the dose should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition. There is no known specific antidote for Desmopressin. The patient should be observed and treated with appropriate symptomatic therapy.
An oral LD50 has not been established. Oral doses up to 0.2 mg/kg/day have been administered to dogs and rats for 6 months without any significant drug-related toxicities reported. An intravenous dose of 2 mg/kg in mice demonstrated no effect.
DOSAGE AND ADMINISTRATION:
Central Diabetes Insipidus:
The dosage of Desmopressin tablets must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients previously on intranasal Desmopressin therapy should begin tablet therapy twelve hours after the last intranasal dose. During the initial dose titration period, patients should be observed closely and appropriate safety parameters measured to assure adequate response. Patients should be monitored at regular intervals during the course of Desmopressin tablets therapy to assure adequate antidiuretic response. Modifications in dosage regimen should be implemented as necessary to assure adequate water turnover. Fluid restriction should be observed.
Adults and Children: It is recommended that patients be started on doses of 0.05 mg (1/2 of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose. Most patients in clinical trials found that the optimal dosage range is 0.1 mg to 0.8 mg daily, administered in divided doses. Each dose should be separately adjusted for an adequate diurnal rhythm of water turnover. Total daily dosage should be increased or decreased in the range of 0.1 mg to 1.2 mg divided into two or three daily doses as needed to obtain adequate antidiuresis. See Pediatric Use subsection for special considerations when administering Desmopressin to pediatric diabetes insipidus patients.
This drug is known to be substantially excreted by the kidney, 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 CLINICAL PHARMACOLOGY, Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)
Primary Nocturnal Enuresis:
The dosage of Desmopressin tablets must be determined for each individual patient and adjusted according to response. Patients previously on intranasal Desmopressin therapy can begin tablet therapy the night following (24 hours after) the last intranasal dose. The recommended initial dose for patients age 6 years and older is 0.2 mg at bedtime. The dose may be titrated up to 0.6 mg to achieve the desired response.
Desmopressin Tablets are available as:
0.1 mg: White, oval, flat-faced, beveled-edge scored tablet. Debossed with WPI on one side and 22/25 on the scored side. Available in bottles of: 100 Tablets NDC 0591-2464-01
0.2 mg: White, oval, flat-faced, beveled-edge scored tablet. Debossed with WPI on one side and 22/26 on the scored side. Available in bottles of: 100 Tablets NDC 0591-2465-01
Dispense in a tight, light-resistant container with a child-resistant closure.
Store at 20° to 25°C (68° to 77°F).
Avoid exposure to excessive heat or light.
Keep out of the reach of children.
Watson Laboratories, Inc.
Corona, CA 92880
Watson Pharma, Inc.
Corona, CA 92880 USA
Revised: July 2011 195817-1
Desmopressin 0.2mg Tablet
Structural Formula of Desmopressin acetate
Desmopressin 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.
Desmopressin 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.
Desmopressin 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.
Desmopressin 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.
Desmopressin 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.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Desmopressin?
Depending on the reaction of the Desmopressin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Desmopressin 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 Desmopressin 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.
Reviewsdrugs.com conducted a study on Desmopressin, 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 Desmopressin 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.
Visitor reported usefulNo survey data has been collected yet
Visitor reported side effectsNo survey data has been collected yet
Visitor reported price estimatesNo survey data has been collected yet
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The information was verified by Dr. Arunabha Ray, MD Pharmacology