Prescribing Guidelines for Lactose Intolerance and … · Prescribing Guidelines for Lactose Intolerance and ... 3. BDA Paediatric Group (2008) Paediatric Group Position Statement

Prescribing Guidance for Lactose intolerance and CMPA KT Feb 14 review Feb16 Draft

Prescribing Guidelines for Lactose Intolerance and

Cows’ Milk Protein Allergy Aim To clarify which products and in which circumstances milk substitutes can be prescribed for babies and young children in primary care, as well as to give a guide to prescribing quantities and duration of treatment. Background NICE produced guideline 116 in Feb 2011 relating to Food allergy in children and young people, it covers the diagnosis and assessment of food allergy in children and young people in primary care and community settings. The care pathway from NICE which covers initial recognition to referral to specialist is attached. Summary • It is important to distinguish between CMPA and lactose intolerance for effective

management. • A limited range of products (foods/milk substitutes) can be prescribed as drugs,

and these are defined in Borderline substances. Any prescription written needs to be marked ‘ACBS’

• It is acknowledged that infants will present to Health Visitors and GP practices with suspected intolerances to infant formula and it will not always be appropriate to wait for a diagnosis from secondary care but rather it is necessary to treat empirically.

• Soya based formulas are not recommended for prescribing to infants, especially those under 6 months of age .The reason for this is the risk that the baby may develop a secondary soya allergy. Soya milk also contains phytoestrogens which are an unproven health risk, particularly for male babies. (Babies of vegan mothers who choose not to breast feed may be given soya milk but not at the expense of the NHS).

• Lactose free milks can be bought at a similar cost to standard infant formula and prescribers should consider the need to prescribe at the expense of the NHS. The NHS Tees formulary lists suitable formulas which are available from pharmacies and many supermarkets will stock on demand.* Healthy start vouchers can be used towards lactose free infant formulas well as standard formula milk. *Parents should be directed towards a pharmacy to purchase lactose free milk; Boots for example keep the milk in the dispensary rather than on the open shelves. Many supermarkets do not routinely stock lactose free infant formula milk but will order it in on an individual basis, pharmacies can obtain stock the same day if not currently stocked.

Key Points for Cow’s Milk Protein allergy • Adverse reactions to foods, mainly cow’s milk protein, are most common in the

first year of life(1). In infancy the main atopic symptoms are atopic dermatitis, gastrointestinal (GI) symptoms (diarrhoea, blood in stools, vomiting, abdominal distension, colic and constipation) and recurrent wheeze.

• CMPA may be caused by two distinct immune pathologies: IgE- and non IgE- mediated. Acute IgE-mediated reactions (usually within 2 hours) include rash or urticaria, wheeze or vomiting. Delayed reactions may be non IgE-mediated or mixed (>2 hours) including eczema, colic, diarrhoea (see NICE Box 1)


• Suspect CMPA when: a child has one or more signs and symptoms, especially if persistent symptoms affecting different organ systems; when a child has not responded to treatment for atopic eczema reflux or chronic GI symptoms including constipation (2).

• Breast fed infants can display symptoms, as some cow’s milk proteins from the mothers diet may be expressed in breast milk.

• Infants with CMPA should be referred to a paediatric dietitian for diagnosis, support and advice on the need for, and the timing of, re-challenge to cows’ milk to test if the allergy has resolved.

• Most children grow out of their allergy by 18-24 months of age. Key Points for Lactose Intolerance • Lactose intolerance is defined as a non-immune mediated adverse reaction to

food i.e. it is not due to allergy but to a lack of the enzyme lactase. • Primary lactose intolerance is rare; generally lactose intolerance is secondary to

gastroenteritis and is transient, usually lasting around 4 to 6 weeks. • Should be treated with a lactose free formula not a hypoallergenic milk free

formula – see decision aid for suitable formulas. • Lactose free formula can be purchased at a similar price to standard formula and

GP should consider whether prescription is actually necessary; advice to use a lactose free infant formula with appropriate safety netting may be all that is required.

• Symptoms usually resolve in 2-3 days when lactose is removed from the diet and achievement of this confirms diagnosis.

• From the age of 1 year, infants continuing to require lactose free milk should be weaned onto proprietary lactose free milks purchased at supermarkets. (Lactose free infant formula should not be required beyond 18 months).

• Lactose free milk is more cariogenic than standard formula as it contains glucose in place of lactose.

. Managing Cows Milk Protein Allergy Breast milk is the ideal choice for the infant with CMPA with maternal exclusion of cow’s milk and supplementation with calcium (to provide 1000mg calcium daily) for a minimum trial of two weeks. For bottle fed infants an appropriate hypoallergenic formula is required. These formulas vary in palatability and should be introduced as soon as possible. If not accepted initially introduce with incremental mixing with the standard formula. Give a minimum trial of two weeks. It is advisable to inform parents /guardians that these formulas contain glucose, so that they may pay special attention to dental hygiene as new teeth appear. The paediatric dietitian will review and inform the GP of all planned monitoring, the follow up intended and guidance given to parents on weaning and the plan to stop formula milk. Typically the paediatric dietitians will usually recommend challenging with small amounts of cows milk from the age of 12-18 months. In cases of IgE mediated allergy challenges need to be under medical supervision.

By the age of 18months most infants a will have been recommended to (gradually) switch to normal cow’s milk or if this is not tolerated, a commercially available liquid milk substitute (soya or oat) using varieties fortified with calcium


Managing Lactose Intolerance Breast milk remains the ideal choice for the infant with lactose intolerance. Breast fed babies with lactose intolerance can be prescribed Colief at a dose of four drops per feed for 4-6 weeks or until symptoms have resolved. For bottle fed babies, lactose free formula milks are available at a similar price to standard formula. See NHS Tees formulary for details of products available. As lactose intolerance is generally temporary, babies should be re-challenged after 4 to 6 weeks to test if the intolerance has resolved. Re-challenge by introducing an increasing amount of standard formula into the lactose free milk and monitoring for symptoms Other Specialist infant formula Secondary care will lead in prescribing for several special groups of infants and young children. • Pre-term and low birth weight infants ( may also require iron and vitamin

supplements) • Disease specific conditions • Complex food intolerances • Faltering growth • Complex medical cases All such prescribing should be initiated by secondary care. The letter should include details of all planned monitoring and follow up intended and guidance for the GP on when the formula should be stopped. Unsettled Babies For infants who appear unsettled, colicky etc. but are not allergic or intolerant to cow’s milk, there are a range of commercially available milks designed to be easier to digest as well as a range of anti colic medicines which parents may wish to try but should not be prescribed.

Produced in conjunction with the paediatric dietitians across NHS Tees especial thanks to the support from Susanna Earnshaw Lead Paediatric Dietitian for North Tees and Hartlepool NHS Foundation Trust.

REFERENCES 1. Vandenplas Y et al: Guidelines for the diagnosis and management of cow’s milk allergy in infants.

Arch Dis Child 2007;92:902-8 2. NICE Clinical Guideline 116 Food Allergy in children and young people

www.nice.org.uk/guidance/CG116 3. BDA Paediatric Group (2008) Paediatric Group Position Statement on the use of Soya protein for

infants. British Dietetic Association; London.

http://www.nice.org.uk/guidance/CG116


Decision Aid For Use in Primary careCow’s Milk Protein Allergy

Mild to moderate symptomsOne or more of the following symptoms:• Gastrointestinal:

Frequent regurgitation, vomiting, diarrhoea, constipation, blood in stool, iron deficiency anaemia

Persistent distress or colic (? 3 hrsper day –wailing/irritable), for at least 3 days/week over > 3 weeks

• Dermatological:Atopic dermatitis, swelling of the lips or eyelids (angio-oedema), urticariaunrelated to acute infections, drug intake or other causes.

Suitable formula / feedingCow’s milk protein free foods if weaning.Step 1: BreastfeedingIf mother is breastfeeding consider maternal milk free diet, with calcium supplements, for a minimum trial of 2 weeks. (1000mg/day e.g. Sandocal1000)Step 2: Bottlefeeding-Extensivelyhydrolysed formulas (EHF)• Casein Based: Nutramigen

1 & 2 (Mead Johnson)or if taste not tolerated

• Whey based: Aptamil Pepti(Milupa) – contains lactose and less hypoallergenic

Trial for a minimum of two weeks.If symptoms do not improve Step 3: Bottlefeeding - Amino acid based formulas (AAF)If symptoms do not improve after 2 weeks or the child persistently refuses EHF then:• NeocateLCP• NutramigenAATrial for a minimum of two weeks.Step 4: Bottlefeeding- Soya Formula• Can only be used in

infants > 6 months who refuse above formulas Infasoy, Wysoy

• Use with caution as high incidence of soya allergy in children with CMPA allergy

Cows Milk Protein Allergy Severe symptoms

One or more of the following symptoms:• Gastrointestinal:

1. FTT due to chronic diarrhoea and/or regurgitation / vomiting and/or refusal to eat.

2. Iron deficiency anaemia due to occult or macroscopic blood loss

3. Protein losing enteropathy(hypoalbuminaemia)

4. Endoscopic / histologicallyconfirmed enteropathyor severe allergic or eosinophilic colitis

• Dermatological:Exudativeor severe atopic dermatitis with hypoalbuminaemia, or FTT or Iron deficiency anaemia

• Respiratory:Acute laryngoedemaor bronchial obstruction with difficulty breathing

• Systemic reactions:Anaphylactic shock –needs immediate referral to hospital for management

Suitable formula / feeding

Cow’s milk protein free foods if weaning:

1. Breastfeeding:Consider maternal milk free diet with calcium supplements, for a minimum trial of 2 weeks.

2. Amino acid based formulas (AAF):

For a minimum trial of 2 – 4 weeks• NeocateLCP• NutramigenAA

Lactose Intolerance

Symptoms• Watery, explosive

diarrhoea• Perianalexcoriation• ColicSymptoms are usually transient and 2° to GI insult e.g. rotavirus infection

Treatment:• Breastfed babies – lactase

drops (e.g. Colief, 4 drops/feed)

• Formula: lactose free formulas based on CMP e.g. SMA LF or Enfamil O-Lac

• NB these formulas are not cow’s milk protein free and should not be used if CMPA is suspected

• Weaned infants need to avoid solids containing lactose

• Soya is not recommended unless the above are not availableand only in infants >6 months.

DiscontinuationMost children should be able

to revert back to normal formula within 4-6 weeks of GI insult but if symptoms do not improve after two weeks on lactose free diet, consider alternative diagnosis.Children over 1 year should use lactose free milk available from most supermarkets

Parents /guardians should be advised that lactose is substituted with glucose which may cause dental caries.

Notes:• Please refer ALL infants on co w’s milk protein free diets to the

paediatric dietetic service• As the quantity each month will need to be adjusted according to

individual requirements ,do not put milks onto repeat .• Prescription for infant formula will be required up until 1.5 -2 years of

age (if allergy persists), and beyond for older patients with severeallergy who are unable to tolerate commercial cow’s milk substitutes.

Notes • Please refer ALL infants on cow ’s milk protein free diets to the

paediatric dietetic service.• Review repeat prescription quantity at 3 month intervals and adjust

according to current requirements.• Prescription for infant formula may be required up until 1.5 – 2 years

of age (if allergy persists), and beyond for older patients with severe allergy who are unable to tolerate commercial cow ’s milk substitutes.








• Whey based: Aptamil Pepti 1 and 2 (Milupa) -contains lactose and less hypoallergenic


















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For a minimum trial of 2 –4 weeks• NeocateLCP• NutramigenAA

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of age (if allergy persists), and beyond for older patients with severe allergy who are unable to tolerate commercial cow’s milk substitutes.


























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For a minimum trial of 2 –4 weeks• NeocateLCP• NutramigenAA

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of age (if allergy persists), and beyond for older patients with severe allergy who are unable to tolerate commercial cow’s milk substitutes.

Discontinuation Most children should be able to revert back to normal formula within 4 to 6 weeks of GI insult but if symptoms do not improve after two weeks on lactose free diet, consider alternative diagnosis. Children over 1 year should use lactose free milk available from most supermarkets


NHS Tees Infant Formula Formulary

These amounts are based on infants under 6 months being exclusively formula fed and drinking 150ml/kg/day of standard concentration formula ,infants 6-12 months requiring less formula as solid food intake increases and children over 12 months will need 300ml milk substitute.

Product Indication Age suitability Additional Information Re-challenge with cow’s milk Lactose Free Infant Formula SMA LF Lactose

intolerance From Birth From 12mths a commercially

available lactose free milk should be sourced from a supermarket Healthy start vouchers can be used to pay for lactose free milk. More cariogenic than standard formula

4 to 6 weeks starting with 1oz/30ml standard formula in one bottle of lactose free formula a day increasing incrementally

Enfamil O-Lac Lactose intolerance

From Birth

Extensively Hydrolysed Infant Formula Nutramigen lipil1 Cow’s Milk Protein

Allergy From birth Website has information on

introducing formula to baby. More cariogenic than standard formula

IgE mediated allergy will be challenged under the medical supervision. Non IgE the dietitians will advice usually at the age of 12-18months Starting with 1oz/30ml whole milk in one bottle of milk free formula per day increasing incrementally until a full feed of cows milk is tolerated

Nutramigen lipil 2 From 6 months

Aptamil Pepti 1 CMPA and unable to tolerate taste of Nutramigen

From birth Prescribe if above not tolerated due to taste More cariogenic than standard formula

Aptamil Pepti 2 From 6mths

Amino-Acid Based Infant Formula Neocate LCP

Cows Milk Protein Allergy (severe )

From birth Prescribe if above not tolerated after a trial of a minimum of two weeks, or if symptoms severe. More cariogenic than standard formula

Nutramigen AA From birth

Soya Based Infant Formula Infasoy

Infants with Cows milk protein allergy that are unable to tolerate other formula

From 6months Only prescribe if other milks are not tolerated as potential health risk of phytoestrogens for babies fed predominately on soya milk, also high incidence of soya allergy in children with CMPA. Do not prescribe for infants of vegan parents at the cost of the NHS. Health Start vouchers can not be used to purchase soya milk. More cariogenic than standard formula.

From 12-18mths commercially available soya or oat milk is available in most supermarkets. Wysoy

From 6months

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Appendix1 How Much Formula Milk is required? A study on a babies milk consumption showed such variation that it would be inappropriate and misleading to provide a single mean recommended volume. (Aust Paediatr J. 1988 Jun;24(3):186-90)

The Merck Online Medical Library also provides infant calorie requirements of 50 to 55 calories per pound of body weight per day for 0 to 6 months of age and 45 calories per pound per day for 12-month-old infants. (A very rough guide to calorie content of baby milk is 1calorie per ml or 20 calories per oz) A rough guide to volume requirements is 150ml-200ml/kg/day or 2.5 times the weight in pounds. A baby who weighs 5kg (12 lb), for example, would drink approximately 875ml (30 oz) of formula per day. Prescribers should refer to manufacturer’s guidance on individual products Comparative Costs of Infant Formula Based on Chemist +Druggist Oct 13 Standard Formula

Product Presentation Cost per 100g Prescribe Routinely

SMA First Milk £5.99/450g £1.33 No

SMA Extra Hungry £5.99/450g £1.33 No

Cow & Gate First milk £4.79/400g £1.20 No

Cow & Gate Follow On £4.79/400g £1.20 No

Lactose Free


SMA LF £5.90/430g £1.37 No

Enfamil O-Lac £6.02/400g £1.50 No

Thickening formula and Comfort milks


SMA Stay Down £9.67/900g £1.07 No

Enfamil AR £4.51/400g £1.12 No

Cow &Gate Comfort £11.49/900g £1.27 No

Cow’s Milk Protein allergy Extensively Hydrolysed Product Presentation Cost per 100g Prescribe Routinely Nutramigen Lipil 1 £14.66/400g £3.67 Yes Nutamigen lipil 2 £14.66/400g £3.67 Yes Aptamil pepti 1 £14.31/400g £3.58 Yes Aptamil pepti 2 £30.72/900g £3.41 Yes Severe Cow’s Milk Protein allergy Amino Acid based Nutramigen AA £36.12/400g £9.03 Yes Neocate LCP £41.10/400g £10.28 Yes(very rarely required)

http://www.ncbi.nlm.nih.gov/pubmed/3421876

Mead Johnson Nutrition Special Formula Feeding Guides Enfamil O-Lac Lactose-free formula for lactose intolerance. Suitable for use from birth onwards.

Enfamil AR Pre-thickened formula for infant reflux. Suitable for use from birth onwards.

Nutramigen LIPIL 1 Extensively hydrolysed, hypoallergenic formula for infants with cow’s milk allergy. Suitable for use from birth onwards.

Nutramigen LIPIL 2 Extensively hydrolysed, hypoallergenic formula for infants with cow’s milk allergy. Suitable for use from 6 months of age.

Nutramigen AA Hypoallergenic amino acid based formula for infants with severe/multiple food allergy. Suitable for use from birth onwards. Feeding Guide : This table is a guide only, feed your baby on demand unless your healthcare professional advises you otherwise. Use the chart below for the correct amounts of boiled water and powder.

Pregestimil Lipil Extensively hydrolysed, hypoallergenic formula for infants with cow’s milk allergy and / or fat malabsorption. Suitable from 6 months of age onwards.

Preparation guidelines

.

Keeping hungry tummies full

When preparing Neocate LCP for your little one, please follow the guidelines on the tin. Although, always follow any specialist guidance that your Healthcare Professional gives you as they will make recommendations on your baby’s individual requirements.

Don’t alter the recipe unless your Healthcare Professional advises you to.

Your doctor or dietitian should also tell you the appropriate amount of Neocate LCP to give your child.

Guide to the average amount of formula to give your baby from 0 – 12 months:

Approx. age of baby

Approx. weight of baby

Level scoops of Neocate

Cooled boiled water (ml)

Number of feeds in 24 hrs

Birth 3.5 kg 3 90 6 3 months 6 kg 4 120 6 4–6 months 7.5 kg 6 180 5 7–9 months 8.5 kg 7 210 5 10–12 months 9.5 kg 8 240 5

Your baby may need more or less than the amounts suggested, based on advice from your Healthcare Professional.

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Prescribing Guidelines for Lactose Intolerance and … · Prescribing Guidelines for Lactose Intolerance and ... 3. BDA Paediatric Group (2008) Paediatric Group Position Statement