Drugs List

Therapeutic Indications

Uses

Non-serious arthritic pain
Rheumatic pain
Sprains
Strains

Contraindications

Third trimester of pregnancy

Precautions and Warnings

Children under 12 years
Asthma
Breastfeeding
First trimester of pregnancy
History of renal impairment
Peptic ulcer
Second trimester of pregnancy

NSAIDs may provoke or exacerbate asthma
Advise patient to wash hands after use
Avoid broken or inflamed skin
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid occlusive dressings
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
Advise patient to consult a doctor if symptoms persist despite treatment

Patients with a history of renal problems should seek medical advice before using topical ibuprofen products.

In the event of the gel being swallowed, a doctor or nearest casualty department should be contacted.

Try on a small area first.

Pregnancy and Lactation

Pregnancy

Ibuprofen with levomenthol is contraindicated during the 3rd trimester of pregnancy and should be used with caution in the first 2 trimesters.

Whilst no teratogenic effects have been demonstrated in animal experiments, the use of ibuprofen during the first and second trimesters should, if possible, be avoided. NSAIDs have been associated with spontaneous abortions and congenital abnormalities. During the 3rd trimester, Ibuprofen is contraindicated as there is a risk of premature closure of foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. There is limited evidence that drugs which inhibit cyclooxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. The use of systemic ibuprofen is therefore not recommended in women attempting to conceive (Schaefer, 2007).

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 ibuprofen with levomenthol with caution in breastfeeding.

At the time of writing there are is limited published experience concerning the use of Ibuprofen during breast feeding. Ibuprofen appears in breast milk in very low concentrations and unlikely to affect the breast-fed infant adversely. Because of its extremely low levels in breast milk and short half-life ibuprofen is a preferred choice as an analgesic or anti-inflammatory agent in nursing mothers.

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

Abdominal pain
Aggravation of existing asthma
Anaphylaxis
Angioedema
Application site reaction
Asthma
Bronchospasm
Bullous dermatoses
Dyspepsia
Dyspnoea
Hypersensitivity reactions
Non-specific allergic reactions
Pruritus
Purpura
Rash
Urticaria

Presentation

Gel formulation of ibuprofen and levomenthol.

Drugs List

Therapeutic Indications

Uses

Non-serious arthritic pain
Rheumatic pain
Sprains
Strains

Dosage

Adults

Elderly

Children

Additional Dosage Information

Contraindications

Third trimester of pregnancy

Precautions and Warnings

Children under 12 years
Asthma
Breastfeeding
First trimester of pregnancy
History of renal impairment
Peptic ulcer
Second trimester of pregnancy

NSAIDs may provoke or exacerbate asthma
Advise patient to wash hands after use
Avoid broken or inflamed skin
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid occlusive dressings
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
Advise patient to consult a doctor if symptoms persist despite treatment

Patients with a history of renal problems should seek medical advice before using topical ibuprofen products.

In the event of the gel being swallowed, a doctor or nearest casualty department should be contacted.

Try on a small area first.

Pregnancy and Lactation

Pregnancy

Ibuprofen with levomenthol is contraindicated during the 3rd trimester of pregnancy and should be used with caution in the first 2 trimesters.

Whilst no teratogenic effects have been demonstrated in animal experiments, the use of ibuprofen during the first and second trimesters should, if possible, be avoided. NSAIDs have been associated with spontaneous abortions and congenital abnormalities. During the 3rd trimester, Ibuprofen is contraindicated as there is a risk of premature closure of foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. There is limited evidence that drugs which inhibit cyclooxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. The use of systemic ibuprofen is therefore not recommended in women attempting to conceive (Schaefer, 2007).

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 ibuprofen with levomenthol with caution in breastfeeding.

At the time of writing there are is limited published experience concerning the use of Ibuprofen during breast feeding. Ibuprofen appears in breast milk in very low concentrations and unlikely to affect the breast-fed infant adversely. Because of its extremely low levels in breast milk and short half-life ibuprofen is a preferred choice as an analgesic or anti-inflammatory agent in nursing mothers.

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

Abdominal pain
Aggravation of existing asthma
Anaphylaxis
Angioedema
Application site reaction
Asthma
Bronchospasm
Bullous dermatoses
Dyspepsia
Dyspnoea
Hypersensitivity reactions
Non-specific allergic reactions
Pruritus
Purpura
Rash
Urticaria

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: October 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 13 October, 2014.

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

Summary of Product Characteristics: Deep relief. The Mentholatum Company Ltd. Revised March 2014.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ibuprofen Last revised: 15 May, 2014
Last accessed: 13 October, 2014