Drugs List

Administration

For oral administration.

Pivmecillinam tablets should be taken with at least half a glass of water to avoid oesophageal ulceration.

Take preferably with, or immediately after a meal whilst sitting or standing.

Contraindications

Patients with, or at a predisposition to carnitine deficiency
Infants under 3 months
Presence or history of oesophageal strictures and/or obstructive changes in the gastrointestinal tract
Hypersensitivity to penicillins and/or cephalosporins
Acute porphyria

Precautions and Warnings

Renal impairment - (see Dosage; Renal Impairment). Pivmecillinam is excreted mainly by the kidney, therefore raised blood levels of mecillinam may occur if repeated doses are given to patients with impaired renal function.

Monitor hepatic and renal function during prolonged therapy.

Pivmecillinam should be used with caution for long-term or frequently repeated treatment, due to the possibility of carnitine depletion.

Pivmecillinam can cause false - positive urinary glucose ( if tested for reducing substrates).

Pregnancy - (see Pregnancy section).

Breastfeeding - (see Lactation section).

Use in Porphyria

Pregnancy and Lactation

Pregnancy

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 14-17 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

Pivmecillinam can be used during breastfeeding with no effects on the infant anticipated. Trace quantities of mecillinam are excreted into the breast milk. The possible risks to the infant include modified bowel flora, diarrhoea and allergic responses in a hypersensitive infant.

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

Anaphylaxis
Reduction in serum and in total body carnitine
Rash
Urticaria
Pruritis
Angioneurotic oedema
Oesophagal ulceration
Mouth ulceration
Oesophagitis
Allergic reactions
Liver function disorders
Changes in blood counts (thrombocytopenia, granulocytopenia, leucopenia, eosinophilia)
Nausea
Diarrhoea
Vomiting
Dyspepsia
Abdominal pain
Antibiotic associated colitis
Convulsions (especially in high doses or in severe renal impairment)
Joint pain
Interstitial nephritis
Increases in hepatic enzymes
Increases in bilirubin
Headache
Dizziness
Fatigue
Vertigo
Gastrointestinal disorders

Drugs List

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Administration

For oral administration.

Pivmecillinam tablets should be taken with at least half a glass of water to avoid oesophageal ulceration.

Take preferably with, or immediately after a meal whilst sitting or standing.

Contraindications

Patients with, or at a predisposition to carnitine deficiency
Infants under 3 months
Presence or history of oesophageal strictures and/or obstructive changes in the gastrointestinal tract
Hypersensitivity to penicillins and/or cephalosporins
Acute porphyria

Precautions and Warnings

Renal impairment - (see Dosage; Renal Impairment). Pivmecillinam is excreted mainly by the kidney, therefore raised blood levels of mecillinam may occur if repeated doses are given to patients with impaired renal function.

Monitor hepatic and renal function during prolonged therapy.

Pivmecillinam should be used with caution for long-term or frequently repeated treatment, due to the possibility of carnitine depletion.

Pivmecillinam can cause false - positive urinary glucose ( if tested for reducing substrates).

Pregnancy - (see Pregnancy section).

Breastfeeding - (see Lactation section).

Use in Porphyria

Pregnancy and Lactation

Pregnancy

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 14-17 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

Pivmecillinam can be used during breastfeeding with no effects on the infant anticipated. Trace quantities of mecillinam are excreted into the breast milk. The possible risks to the infant include modified bowel flora, diarrhoea and allergic responses in a hypersensitive infant.

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

Effects on Ability to Drive and Operate Machinery

No effects on the ability to drive or operate machinery have been observed.

Counselling

Advise patients to take pivmecillinam tablets with at least half a glass of water, preferably with a meal whilst sitting or standing to avoid oesophageal ulceration.

Side Effects

Anaphylaxis
Reduction in serum and in total body carnitine
Rash
Urticaria
Pruritis
Angioneurotic oedema
Oesophagal ulceration
Mouth ulceration
Oesophagitis
Allergic reactions
Liver function disorders
Changes in blood counts (thrombocytopenia, granulocytopenia, leucopenia, eosinophilia)
Nausea
Diarrhoea
Vomiting
Dyspepsia
Abdominal pain
Antibiotic associated colitis
Convulsions (especially in high doses or in severe renal impairment)
Joint pain
Interstitial nephritis
Increases in hepatic enzymes
Increases in bilirubin
Headache
Dizziness
Fatigue
Vertigo
Gastrointestinal disorders

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 ).

Reference Sources

British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

BNF for Children (2011) Pharmaceutical Press, London.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

Summary of Product Characteristics: Selexid Tablets. Leo Laboratories Ltd. Revised May 2011.