Drugs List

Therapeutic Indications

Uses

Classical migraine: prophylaxis
Cluster headache: prophylaxis
Common migraine: prophylaxis
Vascular headache: prophylaxis

Contraindications

Children under 2 years

Precautions and Warnings

Children aged 2 to 5 years
Breastfeeding
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of seizures
History of urinary retention
Lactose intolerance
Narrow angle glaucoma
Pregnancy
Renal impairment

Advise ability to drive/operate machinery may be affected by side effects
Not all available brands/formulations are licensed for use in children
Oral solution with maltitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Not effective in relieving migraine attacks once in progress
Avoid abrupt withdrawal
Discontinue if symptoms of hepatic disease occur
Advise patient that the effects of alcohol may be potentiated

Pregnancy and Lactation

Pregnancy

Use pizotifen with caution in pregnancy.

Use with caution. Limited data available. The manufacturer advises that use should be avoided unless the potential benefit outweighs the risk.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use pizotifen with caution in breastfeeding.

Pizotifen is found in breast milk. The levels of pizotifen in breast milk is not thought likely to affect the infant though its safety has not established.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Aggression
Agitation
Anxiety
Arthralgia
CNS stimulation
Constipation
Depression
Dizziness
Drowsiness
Dry mouth
Facial oedema
Fatigue
Hallucinations
Hepatitis
Hypersensitivity reactions
Increased appetite
Increases in hepatic enzymes
Insomnia
Jaundice
Muscle cramps
Myalgia
Nausea
Paraesthesia
Rash
Sedation
Seizures
Somnolence
Urticaria
Weight gain
Withdrawal symptoms

Presentation

Oral formulations containing pizotifen

Drugs List

Therapeutic Indications

Uses

Classical migraine: prophylaxis
Cluster headache: prophylaxis
Common migraine: prophylaxis
Vascular headache: prophylaxis

Dosage

Adults

Children

Contraindications

Children under 2 years

Precautions and Warnings

Children aged 2 to 5 years
Breastfeeding
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of seizures
History of urinary retention
Lactose intolerance
Narrow angle glaucoma
Pregnancy
Renal impairment

Advise ability to drive/operate machinery may be affected by side effects
Not all available brands/formulations are licensed for use in children
Oral solution with maltitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Not effective in relieving migraine attacks once in progress
Avoid abrupt withdrawal
Discontinue if symptoms of hepatic disease occur
Advise patient that the effects of alcohol may be potentiated

Pregnancy and Lactation

Pregnancy

Use pizotifen with caution in pregnancy.

Use with caution. Limited data available. The manufacturer advises that use should be avoided unless the potential benefit outweighs the risk.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use pizotifen with caution in breastfeeding.

Pizotifen is found in breast milk. The levels of pizotifen in breast milk is not thought likely to affect the infant though its safety has not established.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Aggression
Agitation
Anxiety
Arthralgia
CNS stimulation
Constipation
Depression
Dizziness
Drowsiness
Dry mouth
Facial oedema
Fatigue
Hallucinations
Hepatitis
Hypersensitivity reactions
Increased appetite
Increases in hepatic enzymes
Insomnia
Jaundice
Muscle cramps
Myalgia
Nausea
Paraesthesia
Rash
Sedation
Seizures
Somnolence
Urticaria
Weight gain
Withdrawal symptoms

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: February 2014

Reference Sources

Summary of Product Characteristics: Sanomigran 1.5mg tablets. Novartis Pharmaceuticals UK Ltd. Revised March 2012.

Summary of Product Characteristics: Sanomigran 0.5mg tablets. Novartis Pharmaceuticals UK Ltd. Revised March 2012.

Summary of Product Characteristics: Sanomigran Elixir. Novartis Pharmaceuticals UK Ltd. Revised January 2014.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 14 September 2017