Name of The Medicinal Product

Desmopressin acetate Tablets 0.1mg Taj Pharma
Desmopressin acetate Tablets 0.2mg Taj Pharma

Qualitative and Quantitative Composition

Each tablet contains 0.1mg Desmopressin acetate

Each tablet contains 0.2mg Desmopressin acetate

For excipients, see 6.1

Pharmaceutical form

Tablet

Clinical particulars

4.1 Therapeutic indications

Desmopressin acetate are indicated for the treatment of vasopressin-sensitive cranial diabetes insipidus or in the treatment of post-hypophysectomy polyuria/polydipsia.

4.2 Posology and method of administration

Treatment of Diabetes Insipidus:

Dosage is individual in diabetes insipidus but clinical experience has shown that the total daily dose normally lies in the range of 0.2 to 1.2mg. A suitable starting dose in adults and children is 0.1mg three times daily. This dosage regimen should then be adjusted in accordance with the patient’s response. For the majority of patients, the maintenance dose is 0.1mg to 0.2mg three times daily.

Post-hypophysectomy polyuria/polydipsia:

The dose of Desmopressin acetate should be controlled by measurement of urine osmolality.

4.3 Contraindications

Desmopressin acetate are contraindicated in cases of cardiac insufficiency and other conditions requiring treatment with diuretic agents.

Before prescribing Desmopressin acetate the diagnoses of psychogenic polydipsia and alcohol abuse should be excluded.

4.4 Special warnings and precautions for use

Care should be taken with patients who have reduced renal function and/or cardiovascular disease. In chronic renal disease the antidiuretic effect of Desmopressin acetate would be less than normal.

Precautions to prevent fluid overload must be taken in:

– conditions characterised by fluid and/or electrolyte imbalance

– patients at risk for increased intracranial pressure

4.5 Interaction with other medicinal products and other forms of interaction

Substances which are known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine and carbamazepine, may cause an additive antidiuretic effect leading to an increased risk of water retention and/or hyponatraemia.

NSAIDs may induce water retention and/or hyponatraemia.

Concomitant treatment with loperamide may result in a 3-fold increase of desmopressin plasma concentrations, which may lead to an increased risk of water retention and/or hyponatraemia. Although not investigated, other drugs slowing transport might have the same effect.

A standardised 27% fat meal significantly decreased the absorption (rate and extent) of a 0.4mg dose of oral desmopressin. Although it did not significantly affect the pharmacodynamic effect (urine production and osmolality), there is the potential for this to occur at lower doses. If a diminution of effect is noted, then the effect of food should be considered before increasing the dose.

4.6. Pregnancy and lactation

Pregnancy:

Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus indicate rare cases of malformations in children treated during pregnancy. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.

Caution should be exercised when prescribing to pregnant women. Blood pressure monitoring is recommended due to the increased risk of pre-eclampsia.

Lactation:

Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 micrograms intranasally) indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.

4.7 Effects on ability to drive and use machines

None

4.8 Undesirable effects

Side-effects include headache, stomach pain and nausea. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including aggression in children have been reported. Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with accompanying symptoms of headache, nausea, vomiting, weight gain, decreased serum sodium and in serious cases, convulsions.

4.9 Overdose

An overdose of Desmopressin acetate leads to a prolonged duration of action with an increased risk of water retention and/or hyponatraemia.

Treatment:

Although the treatment of hyponatraemia should be individualised, the following general recommendations can be given. Hyponatraemia is treated by discontinuing the desmopressin treatment, fluid restriction and symptomatic treatment if needed.

Pharmacological properties

5.1 Pharmacodynamic properties

In its main biological effects, DDAVP does not differ qualitatively from vasopressin. However, DDAVP is characterised by a high antidiuretic activity whereas the uterotonic and vasopressor actions are extremely low.

In a modelling study in which intravenous desmopressin was infused over two hours in healthy adult male subjects, the EC₅₀ value was calculated as 1.7pg/ml based on urinary osmolality and 2.4pg/ml based on urinary volume.

5.2 Pharmacokinetic properties

The absolute bioavailability of orally administered desmopressin varies between 0.08% and 0.16%. Mean maximum plasma concentration is reached within 2 hours. The distribution volume is 0.2 – 0.32 l/kg. Desmopressin does not cross the blood-brain barrier. The oral terminal half-life varies between 2.0 and 3.11 hours.

After oral administration of a single dose of 2 x 200 micrograms desmopressin tablets to healthy subjects, 25% of the subjects had plasma concentrations of desmopressin above 1pg/ml up to at least 14 hours post dosing.

In in vitro studies in human liver microsome preparations, it has been shown that no significant amount of desmopressin is metabolised, and thus human liver metabolism in vivo is not likely to occur. Consequently it is also unlikely that desmopressin will interact with drugs affecting hepatic metabolism. However, formal in vivo interaction studies have not been performed.

About 65% of the amount of desmopressin absorbed after oral administration could be recovered in the urine within 24 hours.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Pharmaceutical particulars

6.1 List of excipients

Lactose monohydrate, Potato starch, Povidone & Magnesium stearate.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C. Keep the container tightly closed.

6.5 Nature and contents of container

30ml High Density Polyethylene (HDPE) bottle with a tamper-proof, twist-off polypropylene (PP) closure with a silica gel desiccant insert. Each bottle contains either 30 or 90 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

None

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Desmopressin Acetate Tablets 0.1mg, 0.2mg Taj Pharma

(Desmopressin acetate)

PATIENT INFORMATION

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet, you may need to use it again
If you have further questions, please ask your doctor or pharmacist
This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Your medicine is called Desmopressin acetate Tablets. They are tablets for oral use only.

they are presented in plastic bottles containing 90 tablets
each tablet contains either 0.1mg or 0.2mg of the active ingredient, Desmopressin acetate
other ingredients in Desmopressin acetate Tablets are lactose monohydrate, potato starch, povidone and magnesium stearate.

What Desmopressin acetate Tablets are and what they are used for

Desmopressin acetate Tablets are for oral use only.

They are available in two strengths, 0.1mg and 0.2mg. The 0.1mg tablets are white, oval, convex tablets, scored on one side and engraved ‘0.1’ on the other side. The 0.2mg tablets are white, round, convex tablets, scored on one side and engraved ‘0.2’ on the other side. They contain Desmopressin acetate, an antidiuretic (reduces urine production).

Desmopressin acetate Tablets are used to treat:

diabetes insipidus (extreme thirst and the continuous production of large volumes of dilute urine) IMPORTANT: This should not be confused with diabetes mellitus (sugar diabetes)
post-hypophysectomy polyuria/polydipsia (extreme thirst and the continuous production of large volumes of dilute urine following surgical removal of the pituitary gland).

Before you take Desmopressin acetate Tablets

Do not take Desmopressin acetate Tablets

if you have a serious heart or kidney disease
if you are taking diuretics (water tablets)
if you drink unusually large quantities of fluids, including alcohol
if you are allergic to any of the ingredients listed.

Please consult your doctor before taking Desmopressin acetate Tablets:

if you are on medication for depression or epilepsy
if you are taking a medicine for pain and/or inflammation containing non-steroidal anti-inflammatory drugs (also known as NSAIDs) e.g indomethacin
if you are taking a medicine containing loperamide, for diarrhoea
if you have a medical condition causing fluid and/or electrolyte imbalance
if you have a medical condition that could be made worse by fluid and/or electrolyte disturbance.

While you are on treatment with Desmopressin acetate Tablets, avoid excessive fluid intake as this may lead to a build up of water in the body.

Pregnancy:

If you are pregnant, please inform your doctor before you take Desmopressin acetate Tablets, as blood pressure monitoring is recommended due to the increased risk of pre-eclampsia. Symptoms of pre-eclampsia include high blood pressure, oedema (swelling due to the build up of fluid) and proteinuria (protein in the urine).

Breast-feeding:

If you are breast-feeding ask your doctor or pharmacist for advice before taking Desmopressin acetate Tablets.

Taking/using other medicines:

Please inform your doctor or pharmacist if you are taking or have recently taken or used any other medicines – even those not prescribed.

How to take Desmopressin acetate Tablets

It is important that you do not take more than the prescribed dose in any 24 hour period.

If you have the impression that the effect of Desmopressin acetate Tablets is too strong or too weak, talk to your doctor or pharmacist.

Treatment of diabetes insipidus:

Your doctor will prescribe the dose most suitable for you. The most common dose in adults and children is one 0.1mg tablet or one 0.2mg tablet taken three times a day.

Post-hypophysectomy polyuria/polydipsia:

Your doctor will prescribe the most suitable dose for you based on the concentration of your urine.

If you take more Desmopressin acetate Tablets than you should:

If you take more Desmopressin acetate Tablets than you should, talk to your doctor or pharmacist immediately.

If you forget to take Desmopressin acetate Tablets:

If you forget to take your tablets, please consult your doctor or pharmacist for advice.

Possible Side Effects

Like all medicines, Desmopressin acetate Tablets can have side effects. Excessive fluid intake may lead to a build up of water which dilutes the salt in the body. This is a serious problem and may lead to convulsions. If you experience an unusually bad or prolonged headache, confusion, unexplained weight gain, nausea or vomiting, stop taking Desmopressin acetate Tablets and tell your doctor immediately or go to the casualty department at your nearest hospital.

Most people taking Desmopressin acetate Tablets find it causes them no problems. Side effects include headache, stomach pain and nausea. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including aggression in children have been reported.

If you experience one or more of these side effects or any other undesirable effects, please inform your doctor or pharmacist.

Storing Desmopressin acetate Tablets

Keep Desmopressin acetate Tablets out of the reach and sight of children.

Do not store above 25°C. Keep the container tightly closed.

Do not remove the silica gel insert from the bottle top.

Other Information

30ml High Density Polyethylene (HDPE) bottle with a tamper-proof, twist-off polypropylene (PP) closure with a silica gel desiccant insert. Each bottle contains either 30 or 90 tablets.

Not all pack sizes may be marketed.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com