DDAVP/Desmopressin Injection

• Keep this leaflet, you may need to read it again
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.

1. What DDAVP Injection is and what it is used for
2. What you need to know before you use DDAVP Injection
3. How DDAVP Injection will be given
4. Possible side effects
5. How to store DDAVP Injection
6. Contents of the pack and other information

• if you are allergic to desmopressin acetate or any of the ingredients of this medicine (listed in section 6)
• if you drink unusually large amounts of fluids
• if you suffer from heart problems or other conditions requiring treatment with diuretics (water tablets)
• if you have low blood sodium levels (hyponatremia)
• if you suffer from syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• if you suffer from a more severe form of chest pain (unstable angina)
• if you suffer from von Willebrand’s disease type IIb and you are given this medicine for bleeding control

Talk to your doctor before taking DDAVP Injection.

Be extra careful with the use of DDAVP Injection:

• in children, elderly patients and patients with blood sodium levels in the lower normal range, as the risk of hyponatraemia (low blood sodium levels) may be increased
• if you suffer from a condition that causes a fluid and/ or salt imbalance e.g. vomiting, diarrhoea, infections or fever
• if you at risk of increased intracranial pressure (pressure inside the skull)
• if you have moderate to severe kidney dysfunction
• if you need to be treated for bleeding several times within two days. The effect of DDAVP Injection may then decrease.
• if you suffer from cardiovascular disease such as blood clots, arteriosclerosis or if you have had angioplasty (artery-opening procedure).
• if you have bladder dysfunction and problems in passing urine.

While using DDAVP Injection, your fluid intake must be limited. In this way, you will prevent fluid overload in your body and a lack of sodium in your blood.

Fluid retention (build-up of water in the body) and/or hyponatraemia (low blood sodium levels), with or without accompanying warning signs or symptoms, may occur during treatment with desmopressin (see section 4 “Possible side effects”). Contact your doctor if you notice these warning signs or symptoms; your doctor may check your weight and sodium levels.

When using DDAVP Injection as a diagnostic agent, fluid intake to quench your thirst must be limited to a maximum of 0.5 litres from 1 hour before to 8 hours after administration.

DDAVP Injection does not reduce the prolonged bleeding time in thrombocytopenia (platelet deficiency).

Tell your doctor if you are taking, have recently taken or might take any other medicines.

DDAVP Injection may have a stronger effect if you are already taking other medications that also affect the fluid and/or salt balance in your body. As a result, your body is more likely to retain too much fluid and your blood sodium levels might decrease.

Examples include:

• medicines to treat very severe pain: opioids
• medicines to treat depression: tricyclic or SSRI antidepressants
• medicines to treat pain and/or inflammation: non-steroidal anti-inflammatory drugs, such as indomethacin, ibuprofen
• chlorpromazine (for the treatment of psychosis or schizophrenia)
• carbamazepine (for the treatment of epilepsy)
• drugs to treat diabetes: sulphonylurea derivatives, such as chlorpropamide

• you should avoid drinking large amount of fluid while you are being treated with DDAVP Injection as this could lead to build up of water which dilutes the salt in the body. This is a serious problem and may lead to convulsions.
• You should only drink enough fluid to satisfy your thirst.

when used for diagnostic purpose (fibrinolytic response, kidney function, or cranial diabetes insipidus), limit fluid intake to no more than 500 ml, from 1 hour before until 8 hours after the dose

If you are pregnant or planning a pregnancy, please inform your doctor before you use DDAVP Injection as blood pressure monitoring is recommended due to the increased risk of pre-eclampsia (a condition in pregnant women that can cause serious complications).

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 using DDAVP Injection.

This medicine contains 3.5 mg sodium (main component of cooking/table salt) in each ampoule. This is equivalent to 0.2% of the recommended maximum daily dietary intake of sodium for an adult.

The usual dose for adults and children is 2 micrograms given by injection either just under the skin (subcutaneous) or into a muscle (intramuscular).

By injection either just under the skin (subcutaneous), into a muscle (intramuscular) or directly into one of your veins (intravenous).

Adults: The usual dose is 1 to 4 micrograms daily

Children and infants: Doses from 0.4 micrograms may be used.

A single dose of 2 micrograms is given to adults and children by injection either just under the skin (subcutaneous) or into a muscle (intramuscular).

The dose for adults, children and infants is 0.4 micrograms per kilogram body weight, administered by intravenous infusion (by drip) over a period of 20 minutes. This dose should be given before surgery or following trauma. Further doses may be administered at 12 hourly intervals.

The dose for adults is 4 micrograms by injection either just under the skin (subcutaneous) or into a muscle (intramuscular). This dose can be given prior to lumbar puncture to prevent headache or after lumbar puncture when headache occurs. This dose may be repeated 24 hours later.

The dose for adults and children is 0.4 micrograms per kilogram body weight, administered by injection directly into one of your veins (intravenous) over a period of 20 minutes.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too much, however, avoid drinking any more fluid and seek medical advice if you have any concerns.

Common (may affect up to 1 in 10 patients):

• headache
• nausea
• abdominal pain
• tachycardia (rapid heartbeat)¹
• flushing (reddening of the skin)¹
• hypotension (low blood pressure)¹
• tiredness

Rare (may affect up to 1 in 1,000 patients):

• dizziness

Not known (frequency cannot be estimated from the available data):

• cerebral ischemia (stroke)²
• acute myocardial infarction (heart attack)²
• blood clots in deep veins, brain or lungs³
• angina pectoris²
• itching
• hives
  ^1. For the treatment of bleeding (high dose) at the time of administration, transient fall in blood pressure with increased heart rate and flushing.
  ^2. Reported in the treatment of bleeding (high dose) and only in patients with a history of, or risk factors for blood clots, heart or blood vessel disease, or if you have had performed an angioplasty (artery-opening procedure).
  ^3. Reported mainly in the treatment of bleeding (high dose).

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: https://yellowcard.mhra.gov.uk. By reporting side effects you can help provide more information on the safety of this medicine.