How many milligrams of zofran can a child take

Ondansetron Effective for Gastroenteritis with Vomiting

MARK EBELL, M.D., M.S.

Am Fam Physician. 2006;74(5):830-831

Clinical Question: Is ondansetron (Zofran) safe and effective for dehydrated children with gastroenteritis?

Setting: Emergency department

Study Design: Randomized controlled trial (double-blinded)

Allocation: Concealed

Synopsis: Although oral rehydration is the treatment of choice for children with gastroenteritis, it can be a challenge when the child cannot keep anything down. This leads to overuse of intravenous hydration, particularly given the time pressures in the emergency department. The authors considered for inclusion in the study any mildly to moderately dehydrated child who had had at least one episode of diarrhea and one episode of vomiting in the previous four hours. Those with a body weight of less than 17 lb 10 oz (8 kg), who were severely dehydrated using standardized symptoms (e.g., clammy or cool skin, very dry mucosa, no tears, moderate tachycardia, no urine for at least six hours, limp, lethargic), and those with significant comorbidities were excluded.

Of the 243 children asked to enroll, 215 underwent randomization (allocation concealed) to ondansetron or placebo. The dose of ondansetron was 2 mg for children who weighed between 17 lb 10 oz and 33 lb (15 kg), 4 mg for those who weighed 33 lb to 66 lb (30 kg), and 8 mg for those who weighed more than 66 lb. The dose was repeated if children vomited within 15 minutes of taking the medicine. The mean age of the children was 28 months, 57 percent were boys, and they had a mean of nine episodes of vomiting and six episodes of diarrhea in the previous 24 hours. Groups were similar at baseline, and analysis was by intention to treat.

Children receiving ondansetron were less likely to vomit while being given liquids (14 versus 35 percent; P = .001; number needed to treat [NNT] = 5), had fewer vomiting episodes (0.18 versus 0.65; P < .001), and were less likely to require intravenous rehydration (14 versus 31 percent; P = .003; NNT = 5). There was no difference in the number of children requiring hospitalization or the percentage returning to the emergency department. The drug was well tolerated, although there was a mean of 0.9 additional episodes of diarrhea for children who received ondansetron.

Bottom Line: Ondansetron, when given to children who are mildly to moderately dehydrated because of diarrhea and vomiting, improves their ability to comply with oral rehydration and reduces the need for intravenous hydration. (Level of Evidence: 1b)

POEMs (patient-oriented evidence that matters) are provided by Essential Evidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, see http://www.essentialevidenceplus.com. Copyright Wiley-Blackwell. Used with permission.

For definitions of levels of evidence used in POEMs, see http://www.essentialevidenceplus.com/product/ebm_loe.cfm?show=oxford.

To subscribe to a free podcast of these and other POEMs that appear in AFP, search in iTunes for “POEM of the Week” or go to http://goo.gl/3niWXb.

This series is coordinated by Sumi Sexton, MD, editor-in-chief.

A collection of POEMs published in AFP is available at https://www.aafp.org/afp/poems.

Zofran Tablets 4 mg - Summary of Product Characteristics (SmPC)

This information is intended for use by health professionals

Zofran^® Tablets 4 mg

Zofran^® Tablets 8 mg

Each tablet contains ondansetron 4 mg or 8 mg (as hydrochloride dihydrate).

Excipient(s) with known effect:

Contains lactose (anhydrous) 81.875 mg or 163.75 mg (see section 4.4).

For the full list of excipients, see section 6.1.

Film-coated tablet.

The 4mg tablets are yellow, oval, film-coated tablet engraved with "GX ET3" on one face and plain on the other.

The 8mg tablets are yellow, oval, film-coated tablet engraved with "GX ET5" on one face and plain on the other.

Adults:

Zofran tablets are indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.

Zofran tablets are indicated for the prevention of post-operative nausea and vomiting (PONV). For treatment of established PONV, administration by injection is recommended.

Paediatric Population:

Zofran is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged ≥6 months.

No studies have been conducted on the use of orally administered ondansetron in the prevention and treatment of PONV in children aged ≥1 month, administration by IV injection is recommended for this purpose.

Posology

Chemotherapy and radiotherapy induced nausea and vomiting (CINV and RINV)

Adults

The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge.

Emetogenic Chemotherapy and Radiotherapy: Zofran can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration.

The recommended oral dose is 8mg taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 8 mg every 12 hours for a maximum of 5 days to protect against delayed or prolonged emesis.

For highly emetogenic chemotherapy a single dose of up to 24 mg Zofran taken with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may be used.

To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Zofran may be continued for up to 5 days after a course of treatment.

The recommended dose for oral administration is 8 mg to be taken twice daily.

Paediatric Population

CINV in children and adolescents (aged 6 months to 17years)

The dose for CINV can be calculated based on body surface area (BSA) or weight – see below. In paediatric clinical studies, ondansetron was given by IV infusion diluted in 25 to 50 mL of saline or other compatible infusion fluidand infused over not less than 15 minutes.

Weight-based dosing results in higher total daily doses compared to BSA-based dosing (see section 4.4).

There are no data from controlled clinical trials on the use of Zofran in the prevention of delayed or prolonged CINV. There are no data from controlled clinical trials on the use of Zofran for radiotherapy-induced nausea and vomiting in children.

Dosing by BSA

Zofran should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m². The single intravenous dose must not exceed 8 mg.

Oral dosing can commence 12 hours later and may be continued for up to 5 days (Table 1).

The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.

Table 1: BSA-based dosing for CINV (aged ≥ 6 months to 17 years)

a The intravenous dose must not exceed 8 mg.

b The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg

Dosing by bodyweight

Weight-based dosing results in higher total daily doses compared to BSA-based dosing (see sections 4.4. and 5.1).

Zofran should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/kg. The single intravenous dose must not exceed 8 mg. Two further intravenous doses may be given in 4-hourly intervals.

Oral dosing can commence 12 hours later and may be continued for up to 5 days (Table 2).

The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.

Table 2: Weight-based dosing for CINV (aged 6 months to 17 years)

a The intravenous dose must not exceed 8 mg.

b The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.

Elderly

No alteration of oral dose or frequency of administration is required.

Patients with Renal Impairment

No alteration of daily dosage or frequency of dosing, or route of administration are required.

Patients with Hepatic Impairment

Clearance of Zofran is significantly reduced and serum half-life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg should not be exceeded.

Patients with Poor Sparteine/Debrisoquine Metabolism

The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required.

Post-operative nausea and vomiting (PONV):

Adults

For the prevention of PONV, ondasetron can be administered orally or by intravenous or intramuscular injection.

The recommended oral dose is 16 mg taken one hour prior to anaesthesia.

For the treatment of established PONV, intravenous or intramuscular administration is recommended.

Paediatric population

PONV in children and adolescents (aged 1 month to 17 years)

Oral formulation:

No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; slow IV injection (not less than 30 seconds) is recommended for this purpose.

Injection:

For prevention of PONV in paediatric patients having surgery performed under general anaesthesia, a single dose of ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0. 1 mg/kg up to a maximum of 4 mg either prior to, at or after induction of anaesthesia.

For the treatment of PONV after surgery in paediatric patients having surgery performed under general anaesthesia, a single dose of Zofran may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4 mg.

There are no data on the use of Zofran in the treatment of PONV in children below 2 years of age.

Elderly

There is limited experience in the use of Zofran in the prevention and treatment of post-operative nausea and vomiting in the elderly, however Zofran is well tolerated in patients over 65 years receiving chemotherapy.

Patients with Renal impairment

No alteration of daily dosage or frequency of dosing, or route of administration are required.

Patients with Hepatic impairment

Clearance of Zofran is significantly reduced and serum half life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg should not be exceeded.

Patients with poor Sparteine/Debrisoquine Metabolism

The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required.

Method of Administration

The tablets should be swallowed whole with liquid.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Concomitant use with apomorphine is contraindicated (see section 4.5 interactions).

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT₃ receptor antagonists. Respiratory events should be treated symptomatically and clinicians should pay particular attention to them as precursors of hypersensitivity reactions.

Ondansetron prolongs the QT interval in a dose-dependent manner (see section 5.1). In addition, post- marketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital long QT syndrome. Ondansetron should be administered with caution to patients who have or may develop prolongation of QTc, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation or electrolyte abnormalities.

Myocardial ischemia has been reported in patients treated with ondansetron. In some cases, predominantly during intravenous administration, the symptoms appeared immediately after administration but recovered with prompt treatment. Therefore, caution should be exercised during and after administration of ondansetron.

Hypokalaemia and hypomagnesaemia should be corrected prior to ondansetron administration.

There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs) (see section 4. 5). If concomitant treatment with ondansetron and other serotonergic drugs is clinically warranted, appropriate observation of the patient is advised.

As ondansetron is known to increase large bowel transit time, patients with signs of subacute intestinal obstruction should be monitored following administration.

In patients with adenotonsillar surgery prevention of nausea and vomiting with ondansetron may mask occult bleeding. Therefore, such patients should be followed carefully after ondansetron.

Patients with rare hereditary problems of galactose intolerance, Lapp lactase-deficiency or glucose- galactose malabsorption should not take this medicine.

Paediatric Population

Paediatric patients receiving ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function.

CINV: When calculating the dose on an mg/kg basis and administering three doses at 4-hour intervals, the total daily dose will be higher than if one single dose of 5 mg/m² followed by an oral dose is given. The comparative efficacy of these two different dosing regimens has not been investigated in clinical trials. Cross-trial comparison indicates similar efficacy for both regimens (see section 5.1).

There is no evidence that ondansetron either induces or inhibits the metabolism of other drugs commonly coadministered with it. Specific studies have shown that there are no interactions when ondansetron is administered with alcohol, temazepam, furosemide, alfentanil, tramadol, morphine, lidocaine, thiopental, or propofol.

Ondansetron is metabolised by multiple hepatic cytochrome P-450 enzymes: CYP3A4, CYP2D6 and CYP1A2. Due to the multiplicity of metabolic enzymes capable of metabolising ondansetron, enzyme inhibition or reduced activity of one enzyme (e.g. CYP2D6 genetic deficiency) is normally compensated by other enzymes and should result in little or no significant change in overall ondansetron clearance or dose requirement.

Caution should be exercised when ondansetron is coadministered with drugs that prolong the QT interval and/or cause electrolyte abnormalities (see section 4. 4).

Use of ondansetron with QT prolonging drugs may result in additional QT prolongation. Concomitant use of ondansetron with cardiotoxic drugs (e.g. anthracyclines (such as doxorubicin, daunorubicin) or trastuzumab), antibiotics (such as erythromycin), antifungals (such as ketoconazole), antiarrhythmics (such as amiodarone) and beta blockers (such as atenolol or timolol) may increase the risk of arrhythmias. (See section 4.4).

Serotonergic Drugs (e.g. SSRIs and SNRIs): There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including SSRIs and SNRIs) (see section 4.4).

Apomorphine: Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated.

Phenytoin, Carbamazepine and Rifampicin: In patients treated with potent inducers of CYP3A4 (i.e. phenytoin, carbamazepine, and rifampicin), the oral clearance of ondansetron was increased and ondansetron blood concentrations were decreased.

Tramadol: Data from small studies indicate that ondansetron may reduce the analgesic effect of tramadol.

Women of childbearing potential

Women of childbearing potential should consider the use of contraception.

Pregnancy

Based on human experience from epidemiological studies, ondansetron is suspected to cause orofacial malformations when administered during the first trimester of pregnancy.

In one cohort study including 1.8 million pregnancies, first trimester ondansetron use was associated with an increased risk of oral clefts (3 additional cases per 10 000 women treated; adjusted relative risk, 1.24, (95% CI 1.03-1.48)).

The available epidemiological studies on cardiac malformations show conflicting results.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

Ondansetron should not be used during the first trimester of pregnancy.

Breast-feeding

Tests have shown that ondansetron passes into the milk of lactating animals. It is therefore recommended that mothers receiving Zofran should not breast-feed their babies.

Fertility

There is no information on the effects of ondansetron on human fertility.

Zofran has no or negligible influence on the ability to drive and use machines.

In psychomotor testing ondansetron does not impair performance nor cause sedation. No detrimental effects on such activities are predicted from the pharmacology of ondansetron

Tabulated list of adverse reactions

Adverse events are listed below by system organ class and frequency. Frequencies are defined as:

very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Very common, common and uncommon events were generally determined from clinical trial data. The incidence in placebo was taken into account. Rare, very rare and not known events were generally determined from post-marketing spontaneous data.

The following frequencies are estimated at the standard recommended doses of ondansetron. The adverse event profiles in children and adolescents were comparable to that seen in adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Symptoms and Signs

There is limited experience of ondansetron overdose. In the majority of cases, symptoms were similar to those already reported in patients receiving recommended doses (see section 4.8). Manifestations that have been reported include visual disturbances, severe constipation, hypotension and a vasovagal episode with transient second-degree AV block Ondansetron prolongs the QT interval in a dose-dependent fashion. ECG monitoring is recommended in cases of overdose.

Paediatric population

Paediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeded estimated ingestion of 4 mg/kg) in infants and children aged 12 months to 2 years.

Management

There is no specific antidote for ondansetron, therefore in all cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate.

Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

The use of ipecacuanha to treat overdose with ondansetron is not recommended, as patients are unlikely to respond due to the anti-emetic action of ondansetron itself.

Pharmacotherapeutic group: Serotonin (5HT3) antagonist, ATC code: A04AA01

Mechanism of action

Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system.

The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

Ondansetron does not alter plasma prolactin concentrations.

Clinical safety and efficacy

The role of ondansetron in opiate-induced emesis is not yet established.

QT Prolongation

The effect of ondansetron on the QTc interval was evaluated in a double blind, randomized, placebo and positive (moxifloxacin) controlled, crossover study in 58 healthy adult men and women.

Ondansetron doses included 8 mg and 32 mg infused intravenously over 15 minutes. At the highest tested dose of 32 mg, the maximum mean (upper limit of 90% CI) difference in QTcF from placebo after baseline-correction was 19. 6 (21.5) msec. At the lower tested dose of 8 mg, the maximum mean (upper limit of 90% CI) difference in QTcF from placebo after baseline-correction was 5.8 (7.8) msec. In this study, there were no QTcF measurements greater than 480 msec and no QTcF prolongation was greater than 60 msec.

Paediatric populationCINV

The efficacy of ondansetron in the control of emesis and nausea induced by cancer chemotherapy was assessed in a double-blind randomised trial in 415 patients aged 1 to 18 years (S3AB3006). On the days of chemotherapy, patients received either ondansetron 5 mg/m² intravenous and ondansetron 4 mg orally after 8 to 12 hours or ondansetron 0.45 mg/kg intravenous and placebo orally after 8 to 12 hours. Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 3 days. Complete control of emesis on worst day of chemotherapy was 49% (5 mg/m² intravenous and ondansetron 4 mg orally) and 41% (0.45 mg/kg intravenous and placebo orally). Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 3 days. There was no difference in the overall incidence or nature of adverse events between the two treatment groups.

A double-blind randomised placebo-controlled trial (S3AB4003) in 438 patients aged 1 to 17 years demonstrated complete control of emesis on worst day of chemotherapy in:

• 73% of patients when ondansetron was administered intravenously at a dose of 5 mg/m² intravenous together with 2 to 4 mg dexamethasone orally

• 71% of patients when ondansetron was administered as syrup at a dose of 8 mg together with 2 to 4 mg dexamethasone orally on the days of chemotherapy.

Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 2 days. There was no difference in the overall incidence or nature of adverse events between the two treatment groups.

The efficacy of ondansetron in 75 children aged 6 to 48 months was investigated in an open-label, non-comparative, single-arm study (S3A40320). All children received three 0.15 mg/kg doses of intravenous ondansetron, administered 30 minutes before the start of chemotherapy and then at 4 and 8 hours after the first dose. Complete control of emesis was achieved in 56% of patients.

Another open-label, non-comparative, single-arm study (S3A239) investigated the efficacy of one intravenous dose of 0.15 mg/kg ondansetron followed by two oral ondansetron doses of 4 mg for children aged < 12 years and 8 mg for children aged ≥ 12 years (total no. of children n = 28). Complete control of emesis was achieved in 42% of patients.

PONV

The efficacy of a single dose of ondansetron in the prevention of post-operative nausea and vomiting was investigated in a randomised, double-blind, placebo-controlled study in 670 children aged 1 to 24 months (post-conceptual age ≥ 44 weeks, weight ≥ 3 kg). Included subjects were scheduled to undergo elective surgery under general anaesthesia and had an ASA status ≤ III. A single dose of ondansetron 0. 1 mg/kg was administered within five minutes following induction of anaesthesia. The proportion of subjects who experienced at least one emetic episode during the 24-hour assessment period (ITT) was greater for patients on placebo than those receiving ondansetron (28% vs. 11%, p <0.0001).

Four double-blind, placebo-controlled studies have been performed in 1469 male and female patients (2 to 12 years of age) undergoing general anaesthesia. Patients were randomised to either single intravenous doses of ondansetron (0.1 mg/kg for paediatric patients weighing 40 kg or less, 4 mg for paediatric patients weighing more than 40 kg; number of patients = 735) or placebo (number of patients = 734). Study drug was administered over at least 30 seconds, immediately prior to or following anaesthesia induction. Ondansetron was significantly more effective than placebo in preventing nausea and vomiting. The results of these studies are summarised in Table 3.

Table 3: Prevention and treatment of PONV in Paediatric Patients – Treatment response over 24 hours

CR = no emetic episodes, rescue or withdrawal

Absorption

Following oral administration, ondansetron is passively and completely absorbed from the gastrointestinal tract and undergoes first pass metabolism. Peak plasma concentrations of about 30 ng/mL are attained approximately 1.5 hours after an 8 mg dose. For doses above 8 mg the increase in ondansetron systemic exposure with dose is greater than proportional; this may reflect some reduction in first pass metabolism at higher oral doses. Mean bioavailability in healthy male subjects, following the oral administration of a single 8 mg tablet, is approximately 55 to 60%. Bioavailability, following oral administration, is slightly enhanced by the presence of food but unaffected by antacids.

The disposition of ondansetron following oral, intramuscular (IM) and intravenous (IV) dosing is similar with a terminal half life of about 3 hours and steady state volume of distribution of about 140 L. Equivalent systemic exposure is achieved after IM and IV administration of ondansetron.

A 4mg intravenous infusion of ondansetron given over 5 minutes results in peak plasma concentrations of about 65 ng/mL. Following intramuscular administration of ondansetron, peak plasma concentrations of about 25 ng/mL are attained within 10 minutes of injection.

Following administration of ondansetron suppository, plasma ondansetron concentrations become detectable between 15 and 60 minutes after dosing. Concentrations rise in an essentially linear fashion, until peak concentrations of 20-30 ng/mL are attained, typically 6 hours after dosing. Plasma concentrations then fall, but at a slower rate than observed following oral dosing due to continued absorption of ondansetron. The absolute bioavailability of ondansetron from the suppository is approximately 60% and is not affected by gender. The half life of the elimination phase following suppository administration is determined by the rate of ondansetron absorption, not systemic clearance and is approximately 6 hours. Females show a small, clinically insignificant, increase in half-life in comparison with males.

Distribution

Ondansetron is not highly protein bound (70-76%).

Biotransformation and Elimination

Ondansetron is cleared from the systemic circulation predominantly by hepatic metabolism through multiple enzymatic pathways. Less than 5% of the absorbed dose is excreted unchanged in the urine. The absence of the enzyme CYP2D6 (the debrisoquine polymorphism) has no effect on ondansetron's pharmacokinetics. The pharmacokinetic properties of ondansetron are unchanged on repeat dosing.

Special Patient Populations:

Gender

Gender differences were shown in the disposition of ondansetron, with females having a greater rate and extent of absorption following an oral dose and reduced systemic clearance and volume of distribution (adjusted for weight).

Children and Adolescents (aged 1 month to 17 years)

In paediatric patients aged 1 to 4 months (n=19) undergoing surgery, weight normalised clearance was approximately 30% slower than in patients aged 5 to 24 months (n=22) but comparable to the patients aged 3 to 12 years. The half-life in the patient population aged 1 to 4 month was reported to average 6.7 hours compared to 2.9 hours for patients in the 5 to 24 month and 3 to 12 year age range. The differences in pharmacokinetic parameters in the 1 to 4 month patient population can be explained in part by the higher percentage of total body water in neonates and infants and a higher volume of distribution for water soluble drugs like ondansetron.

In paediatric patients aged 3 to 12 years undergoing elective surgery with general anaesthesia, the absolute values for both the clearance and volume of distribution of ondansetron were reduced in comparison to values with adult patients. Both parameters increased in a linear fashion with weight and by 12 years of age, the values were approaching those of young adults. When clearance and volume of distribution values were normalised by body weight, the values for these parameters were similar between the different age group populations. Use of weight-based dosing compensates for age- related changes and is effective in normalising systemic exposure in paediatric patients.

Population pharmacokinetic analysis was performed on 428 subjects (cancer patients, surgery patients and healthy volunteers) aged 1 month to 44 years following intravenous administration of ondansetron. Based on this analysis, systemic exposure (AUC) of ondansetron following oral or IV dosing in children and adolescents was comparable to adults, with the exception of infants aged 1 to 4 months. Volume was related to age and was lower in adults than in infants and children. Clearance was related to weight but not to age with the exception of infants aged 1 to 4 months. It is difficult to conclude whether there was an additional reduction in clearance related to age in infants 1 to 4 months or simply inherent variability due to the low number of subjects studied in this age group. Since patients less than 6 months of age will only receive a single dose in PONV a decreased clearance is not likely to be clinically relevant.

Elderly

Early Phase I studies in healthy elderly volunteers showed a slight age-related decrease in clearance, and an increase in half-life of ondansetron. However, wide inter-subject variability resulted in considerable overlap in pharmacokinetic parameters between young (< 65 years of age) and elderly subjects (≥ 65 years of age) and there were no overall differences in safety or efficacy observed between young and elderly cancer patients enrolled in CINV clinical trials to support a different dosing recommendation for the elderly.

Based on more recent ondansetron plasma concentrations and exposure-response modelling, a greater effect on QTcF is predicted in patients ≥75 years of age compared to young adults. Specific dosing information is provided for patients over 65 years of age and over 75 years of age for intravenous dosing.

Renal impairment

In patients with renal impairment (creatinine clearance 15-60 mL/min), both systemic clearance and volume of distribution are reduced following IV administration of ondansetron, resulting in a slight, but clinically insignificant, increase in elimination half-life (5.4 hours). A study in patients with severe renal impairment who required regular haemodialysis (studied between dialyses) showed ondansetron's pharmacokinetics to be essentially unchanged following IV administration.

Hepatic impairment

Following oral, intravenous or intramuscular dosing in patients with severe hepatic impairment, ondansetron's systemic clearance is markedly reduced with prolonged elimination half-lives (15-32 hours) and an oral bioavailability approaching 100% due to reduced pre-systemic metabolism. The pharmacokinetics of ondansetron following administration as a suppository have not been evaluated in patients with hepatic impairment.

Embryo-fetal development studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during the period of organogenesis at approximately 6 and 24 times respectively the maximum recommended human oral dose of 24 mg/day, based on body surface area. In a pre- and postnatal developmental toxicity study, there were no effects upon pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance at approximately 6 times the maximum recommended human oral dose of 24 mg/day based on body surface area.

Lactose

Microcrystalline cellulose

Pregelatinised maize starch

Magnesium stearate

Methyl hydroxypropyl cellulose

Titanium dioxide (E171)

Iron oxide (E172)

Not applicable.

36 months

Store below 30°C.

Zofran Tablets 4mg come in blister packs of 10 or 30 tablets comprising aluminium/PVC blister film and aluminium foil lidding. Securitainer packs of 30 or 100 tablets.

Zofran Tablets 8 mg come in blister packs of 10, 15, or 30 tablets comprising aluminium/PVC blister film and aluminium foil lidding. Securitainer packs of 30 or 100 tablets.

Not all pack sizes may be marketed.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Novartis Pharmaceuticals UK Limited

2nd Floor, The WestWorks Building, White City Place,

195 Wood Lane,

London, W12 7FQ

United Kingdom

Zofran Tablets 4 mg - PL 00101/0981

Zofran Tablets 8 mg - PL 00101/0982

Date of first authorisation: 01 December 1993

Date of latest renewal: 09 January 2002

12 January 2022

LEGAL CATEGORY

POM

Zofran, 2 mg/ml, solution for intravenous and intramuscular administration, 2 ml, 5 pcs.

Zofran - antiemetic.

Pharmacodynamics

Ondansetron is a selective 5-HT3 receptor antagonist. Drugs for cytostatic chemotherapy and radiotherapy can cause an increase in the level of serotonin, which, by activating vagal afferent fibers containing 5-HT 3 receptors, causes a gag reflex. Ondansetron inhibits the appearance of a gag reflex by blocking 5-HT 3 receptors at the level of neurons of both the central nervous system and the peripheral nervous system.

Pharmacokinetics

Ondansetron is completely absorbed from the gastrointestinal tract after oral administration and undergoes first pass metabolism through the liver. Cmax in plasma is reached approximately 1.5 hours after ingestion. Bioavailability is somewhat increased with concomitant food intake, but does not change with antacids.

The distribution of ondansetron is the same for oral, intramuscular and intravenous administration; T 1 / 2 is approximately 3 hours, in elderly patients it can reach 5 hours, and with severe renal failure - 15-20 hours. The volume of distribution when an equilibrium concentration is reached is about 140 liters. Plasma protein binding is 70-76%. After rectal administration, ondansetron is determined in plasma after 15-60 minutes. The concentration of the active substance increases linearly, Cmax is reached after about 6 hours and is 20–30 ng/ml. The decrease in plasma concentration occurs at a slower rate than after oral administration (due to continued absorption). T 1/2 - 6 hours. Absolute bioavailability with rectal administration - 60%.

It is eliminated from the systemic circulation mainly as a result of metabolism in the liver, which occurs with the participation of several enzyme systems. The absence of the CYP2D6 enzyme (spartein-debrisoquine type polymorphism) does not affect the pharmacokinetics of ondansetron. Less than 5% of the administered dose is excreted unchanged in the urine.

At doses above 8 mg, blood levels increase disproportionately, because when prescribing high doses orally, metabolism during the first passage through the liver may decrease.

The pharmacokinetic parameters of ondansetron do not change with repeated administration.

In patients with moderate renal insufficiency (Cl creatinine - 15-60 ml / min), both systemic clearance and volume of distribution of ondansetron are reduced, resulting in a small and clinically insignificant increase in its T 1/2 (up to 5.4 h) . The pharmacokinetics of ondansetron remains virtually unchanged in patients with severe renal impairment on chronic hemodialysis. In patients with severe hepatic impairment, the systemic clearance of ondansetron is sharply reduced, resulting in an increase in its T 1/2 (up to 15-32 hours), and oral bioavailability reaches 100% due to a decrease in first-pass metabolism.

Special patient groups

Sex

The pharmacokinetics of ondansetron depends on the sex of the patients. Women have lower systemic clearance and volume of distribution (values ​​adjusted for body weight) than men.

Children and adolescents (aged 1 month to 17 years)

In a clinical study, children aged 1 to 24 months (51 patients) received ondansetron at a dose of 0.1 mg/kg or 0.2 mg/kg up to surgical intervention. In patients aged 1 to 4 months, Cl was approximately 30% lower than in patients aged 5 to 24 months, but comparable to this indicator in patients aged 3 to 12 years (with correction for indicators depending on weight bodies). T 1/2 in the group of patients aged 1-4 months averaged 6.7 hours; in the age groups 5–24 months and 3–12 years — 2.9h. In patients aged 1 to 4 months, dose adjustment is not required, since a single intravenous injection of ondansetron is used to treat postoperative nausea and vomiting in this category of patients. Differences in pharmacokinetic parameters are partly explained by a higher volume of distribution in patients aged 1 to 4 months.

In a study in children aged 3–12 years (21 patients) undergoing elective surgery under general anesthesia, the absolute values ​​of Cl and volume of distribution of ondansetron after a single intravenous dose of 2 mg (from 3 to 7 years) or 4 mg (8 to 12 years) were reduced compared to adult values. Both parameters increased linearly with body weight, in patients aged 12 years, these values ​​approached those in adults. When correcting the values ​​of clearance and volume of distribution, depending on body weight, these parameters were similar in different age groups. The weight-adjusted dose (0.1 mg/kg, up to a maximum of 4 mg) compensates for these changes and for the systemic exposure of ondansetron in children.

A population pharmacokinetic analysis was performed in 74 patients aged 6 to 48 months who received ondansetron 0.15 mg/kg IV every 4 hours for 3 doses for the relief of chemotherapy-induced nausea and vomiting and in 41 patients aged 1 to 24 months after surgery who received ondansetron at a single dose of 0. 1 or 0.2 mg/kg. Based on the pharmacokinetic parameters in this group, for patients aged 1 to 48 months, the administration of ondansetron IV at a dose of 0.15 mg/kg every 4 hours in the amount of 3 doses should lead to a systemic exposure comparable to that observed with the use of the drug at the same doses in children aged 5 to 24 months in surgical interventions, as well as in previous studies in children with cancer (aged 4 to 18 years) and in surgical intervention (aged 3 to 12 years ).

Elderly patients

Studies have shown a slight, clinically insignificant, age-dependent increase in T 1/2 of ondansetron.

Patients with impaired renal function

In patients with moderate renal impairment (Cl creatinine 15–60 ml/min), intravenous administration of ondansetron reduces both systemic clearance and volume of distribution of ondansetron, resulting in a small and clinically insignificant increase T 1/2 (up to 5.4 h). The pharmacokinetics of ondansetron when administered intravenously remained practically unchanged in patients with severely impaired renal function on chronic hemodialysis (studies were conducted between hemodialysis sessions).

Patients with impaired liver function

In patients with severely impaired liver function, the systemic clearance of ondansetron decreases sharply with an increase in T 1/2 to 15–32 hours. be in the first aid kit for children

Ksenia Petrova

updated the first aid kit for children

Author profile

My husband and I are doctors, and even before the birth of the child, we collected a first aid kit for children the size of an ambulance paramedic's bag.

We didn't use it the first year, but when the child started kindergarten, I looked in the first aid kit every week or more.

Most of the drugs were not useful, so I decided to sort out the first aid kit. I made a list of situations that can be handled at home, and figured out what to put in it.

For convenience, I have divided the disease states:

• Pain
• Fever
• Cough

Pain

If the child is in pain and this pain interferes with sleep and play, give painkillers. The exception is abdominal pain. Call an ambulance if you suspect that the child has a stomachache.

What is possible. Choose painkillers according to age: preparations with paracetamol are suitable for children from birth, preparations with ibuprofen - from three months. There is no difference in what form to give the medicine: the effectiveness of suppositories or syrup is the same.

/colic/

How to help a newborn with colic

If your child has earaches, a local anesthetic can be used, such as heated Otipax. But its effect is weaker and the action is shorter than that of ibuprofen. If the pain persists for 48-72 hours and does not go away with the combined use of ibuprofen and Otipax, contact your doctor. He will prescribe antibiotic drops. Do not use them without a doctor's prescription.

What is not needed. Do not use lidocaine gels to relieve pain during teething. In the United States, the Food and Drug Administration banned such gels due to frequent cases of poisoning in children.

FDA: recommendations for the use of lidocaine gels for teething

In Russia, gels are sold in pharmacies, but pediatricians recommend helping children conservatively: give chilled teethers, massage the gums, give painkillers no more than twice a week if the child does not sleep well at night .

Do not use warming or cooling oils or herbal extracts for ear pain.

What to buy:
💊 Candles with ibuprofen — from 64 Р
💊 Solution with paracetamol - from 80 R
💊 "Otipax" - from 377 R

Fever

It is necessary to give an antipyretic during a cold if the temperature is above 38 °C, the child is lethargic, complains of pain. If the temperature is below 38 ° C and the child is actively playing, then antipyretics are not needed.

What you need. Children from birth can be given paracetamol in the first days of a cold. Children older than six months - ibuprofen. They can be used 2 times a day for 3 days. If the temperature persists longer, call the pediatrician.

/molodoy-papa/

How much I spent on a child in the first year

What is not needed. Children's first aid kit should not contain acetylsalicylic acid. It can cause Reye's syndrome, a rare but serious disease that affects the liver and brain. Children under 12 years of age are not recommended drugs that contain nimesulide, such as Nise. It can be toxic to the liver. Pediatricians prescribe drugs with nimesulide to children over 12 years of age only if other antipyretic drugs have not helped.

Why is acetylsalicylic acid dangerous? Therefore, the American Academy of Pediatrics does not recommend giving children under six years of age over-the-counter cough medicines.

What is possible. Honey or corn syrup. They can be given to children from the age of 1.5-2 teaspoons 2-3 times a day, with water or tea.

Oxford University scientists reviewed research on the benefits of honey in fighting cough. The conclusion is that honey reduces the frequency and severity of coughs better than over-the-counter drugs. WHO also recommends honey and corn syrup for children from 2 years 6 months. Honey is not recommended for children under one year old due to the risk of botulism.

Children over 6 years of age can be given lozenges and lozenges: during sucking, a lot of saliva is released, and it itself has an antiseptic effect, so any will do.

Verywellfamily: American Academy of Pediatrics Cough Tips

BMJ: Systematic Review of Honey for Cough Treatment

WHO: Cough Management Guidelines

Rospotrebnadzor: Intestinal Botulism and Honey

What is not needed. Do not buy mucolytics for your first aid kit - products that dilute sputum. They should not be given to children under 2 years of age, because the risk of side effects is higher than the possible benefit: coughing may increase or respiratory failure may occur.

Mucolytics are also not recommended for healthy older children without bronchopulmonary disease and adults because there is no evidence of effectiveness. These drugs include acetylcysteine, carbocysteine, ambroxol, bromhexine, sobrerol, neltenexin, erdosteine, and telmesteine.

Children under 18 should not use codeine cough suppressants. This is a narcotic substance that can cause respiratory failure. Sometimes it is added to cough remedies in combination with other components. So read the ingredients on the label. It is impossible to buy a drug with codeine without a prescription, but there is a risk that old drugs are lying around in the pharmacy.

Italian Pharmacovigilance Authority: why children should not be given mucolytics

FDA: when to give children cough medicines

Other antitussives, expectorants and herbal remedies will not help with coughs. Just like steam and aerosol inhalers: cool moist air helps better, if only because it cannot provoke a burn of the respiratory tract, unlike a steam inhaler.

What to buy:
💊 Lozenges with antiseptic — 213 R
💊 Corn syrup — 465 R
💊 Bank of honey 0. 5 kg in St. Petersburg — 490 R

Runny nose

Runny nose is a normal reaction to an infection, allergy or dry air. Do not fight him if the child sleeps, eats and plays calmly. Relieve a runny nose only if the child is uncomfortable.

What is possible. Saline solution: this may be 0.9% sodium chloride solution, Aquamaris, Aqualor, or similar. Children under one year old need to choose funds in drops, older children can use both drops and spray. For children who do not yet know how to blow their nose, a nasal aspirator will come in handy so that the parent can suck out the discharge.

UpToDate: recommendations for the treatment of non-allergic rhinitis

Vasoconstrictive drops can be instilled in children from birth in a short course, no longer than 3 days. This is justified if the nose is very stuffy and the child cannot suckle, eat or sleep because of this. Drops containing phenylephrine 0.125%, xylometazoline 0.5% or oxymetazoline 0. 01-0.025% are allowed for children under 6 years of age.

What is not needed. There is no evidence that vasoconstrictor drops and antihistamines treat the common cold. In children under 6 years of age, they can cause side effects: headache, insomnia, drowsiness, heart rhythm disturbances, and if used for more than seven days, chronic nasal congestion. Therefore, in the UK and America, they are not used in children under 6 years old, and from 6 to 12 years old - only as directed by a doctor.

BMJ: Which medicines are effective for treating colds in children and adults

Medscape: FDA warning about the dangers of using over-the-counter cold medicines

Do not use interferons to treat the common cold, they are ineffective.

What to buy:
💊 Salt solution in drops - from 114 p
💊 Nazalnaya aspirator - 171 p
💊 Drops with phenylefrin for children to a year - from 192 p

Construction

Constipation - this is a state in which the intestines are intestines emptying less than 3 times a week. More often than not, children just need to exercise, eat more fiber, and drink more water. If this does not help, you can resort to a first-aid kit once.

What is possible. First-line drugs for the treatment of constipation in children from birth - laxative syrups based on polyethylene glycol, such as Macrogol, or lactulose-based: Dufalac and Normaze.

American Academy of Family Physicians: Evaluation and Management of Constipation in Children and Adolescents

Laxatives should be taken from 4 weeks to 4 months if constipation recurs every month or more. The fact that laxatives are addictive and the intestines stop working on their own is a myth. With the right dose and duration of treatment, this will not happen. Therefore, the doctor prescribes the dosage and dosage regimen.

Before taking laxatives, you need to do an enema if there was no stool for 3-5 days: otherwise, a plug of dense stool will prevent the intestines from emptying. This will make the child's stomach hurt.

Community 26.01.21

What to do with constipation?

An enema will soften hard stools, and they will easily pass out of the intestines. It can be done from birth by filling the syringe with 0.9% sodium chloride solution. You can buy a 500 ml bottle of saline and store it at room temperature for three years.

Select the volume of the enema syringe according to age

What is not needed. The European and American Societies of Pediatrics and Gastroenterology consider probiotics and prebiotics to be ineffective in the treatment of constipation. There is also no evidence in favor of treating constipation with choleretic and antihelminthic drugs.

Clinical Guideline: assessment and treatment of constipation in children

What to buy:
0123 💊 Saline, 500 ml - 318 Р

Diarrhea

According to WHO, diarrhea in children older than one year is loose stools that appear more than 3 times a day. Diarrhea in infants - when the stool becomes 2 times more frequent than the usual frequency of defecation.

WHO: facts about diarrhea

Diarrhea peaks within 12-36 hours, is accompanied by repeated diarrhea, and there may be cramping abdominal pain. In the first hours of illness, it is important to replenish fluid loss in order to prevent dehydration.

What is possible. Buy a supply of oral rehydration powders from your first aid kit. Children from birth can be given Humanta Electrolyte. From the age of 3 - "Rehydron bio". Ordinary water does not replenish calories and salt reserves, and too salty solution will increase diarrhea. Therefore, it is easier not to experiment with salt and sugar, but to dilute the powder and give the child a drink according to the instructions.

It is acceptable to replenish fluid loss with diluted juices, compotes and weak tea if the child refuses to drink diluted powders.

What is not needed. Antidiarrheal drugs, such as Imodium and Loperamide, as well as sorbents, such as Enterosgel, are not recommended for use in diarrhea in children. They increase the risk of complications of the disease and do not affect the rate of recovery in any way.

Normally, the stool is restored up to 10 days. Probiotics can reduce diarrhea by up to one day, as can sorbents such as Smecta. Zinc supplements can reduce stool volume, but only by 30%, which can cause diarrhea to end a day earlier. But there may not be a positive effect, so they are not recommended as a mandatory treatment for diarrhea in children.

CDC: Treatment of Acute Gastroenteritis in Children

UpToDate: Probiotics to Prevent and Treat Diarrhea

Cochrane: Effectiveness of Smectite in Treatment of Diarrhea in Children

What to Buy:


💊 Regidron Bio, set of 5 powders - 405 R
💊 Humana Electrolyte, set of 12 powders - 1990 R

Vomiting

If vomiting is repeated, act in the same way as for diarrhea: avoid dehydration with powders for oral rehydration. When vomiting arises from motion sickness in transport and makes the trip impossible, there is a way out.

What is possible. In children under 2 years of age, the vestibular apparatus is not fully developed and they rarely get sick. Therefore, they are not recommended to give drugs to prevent motion sickness. From birth to 3 years of age, medication is prescribed only by a doctor.

From the age of 3 you can give an over-the-counter drug with Dramamine, it is also suitable for adults. But it has many side effects: drowsiness, headache, dizziness may appear. Therefore, do not give the drug to a child if he is only worried about nausea, but there is no vomiting.

Drugs.com: Dramamine drug recommendations

What not to do. Other drugs for nausea and vomiting will not work. Some are available only by prescription, such as Diphenhydramine and Zofran, others have many side effects, such as Cerucal, and others, such as ginger tea, have no proven effectiveness.

What to buy:
💊 "Dramina" for children from three years old - 171 Р
💊 "Rehydron bio", a set of 5 powders - 405 Р

Allergy

Allergies may cause a runny nose with watery discharge, sneezing, itching, watery eyes. In addition, 20% of people have an allergic reaction like urticaria at least once in their lives. Most often, urticaria disappears on its own within 6 weeks.

Royal College of Physicians: symptoms and treatment of urticaria

Allergy and immunity: all about urticaria

Allergy symptoms

What can. It is preferable to give second-generation antihistamines until the rash or itching subsides. Children from one year old can be given "Cetirizine" or "Desloratadine": you need to dose according to the instructions - from the minimum to the maximum allowable dose, if there is no effect. For children under one year old, the pediatrician or allergist prescribes the drug and dose.

Chilled "Fenistil-gel" or products with calamine and cindol can be used to relieve itching. And to alleviate an allergic rhinitis, the same rinsing of the nose with saline is suitable.

/asit/

How to treat allergies with ASIT

What not to do. No need to buy steroid creams to relieve allergic itching, they will not help with this.

Children are not recommended to give first-generation antihistamines such as Diphenhydramine and chloropyramine, which is part of the popular Suprastin. They cause side effects such as drowsiness and trouble breathing.

For example, "Fenistil" in drops is allowed from a month, but manufacturers recommend using up to a year with caution and as prescribed by a doctor, because at this age "Fenistil" can provoke episodes of sleep apnea, when breathing stops for a few seconds.

Analogues of expensive allergy medicines

The Village: 19 myths about allergies

What to buy:
0093

The child will inevitably have wounds and abrasions. Stock up on wound care products to prevent infection.

What is possible. Non-alcoholic antiseptics such as miramistin and chlorhexidine are suitable for treating wounds with skin damage. Buy bandages, bactericidal and tape plasters to bandage the wound after treatment. An antiseptic is also useful for treating intact skin of the hands so that the child does not infect the wound.

If the child has a nosebleed, only a bandage or wipes will be needed. Apply them to the ends of the nostrils without pushing inward, and pinch your nose for 10 minutes.

Medical news today: what to do if your child has a nosebleed

What not to do. A germicidal patch will be sufficient to avoid infection of a small wound. If pus appears in the wound, consult a doctor: he will prescribe antibiotics. You cannot take them on your own: with uncontrolled use of antibiotics, the infection becomes resistant to them and it will be more difficult to cure it.

Do not use alcoholic solutions on wounds, umbilical cord, or chickenpox rash. Especially those containing aniline dyes, such as brilliant green. For children under one year old, such dyes are toxic, and for older ones they are ineffective.

CDC: Treatment of chickenpox at home

What to buy:
💊 chlorhexidine - 15 p
💊 gauze bandage - 54 p
💊 Bactericidal patch - 55 p
💊 CEOLEDELLECTIVAR - 109 P

BUIK

get burned from the sun, plants and open fire. If the burn is larger than the baby’s palm and blisters appear in its place, or the face, genitals are burned and the child feels unwell, consult a doctor. With light and small burns, you can help yourself.

What is possible. After the wound has been washed and cooled, treat it with an antibiotic ointment such as bacitracin. This will prevent the development of infection. Then cover the wound with a bandage. For a burn wound, stock up on a pair of atraumatic dressings: they do not stick to the wound and it does not hurt to change them.

UpToDate: Prevention and Treatment of Burns

Give pain medication, such as ibuprofen, if the burn hurts and keeps the child awake. When the burn heals, the wound itches. To prevent your child from scratching it, use calamine lotion to reduce itching.

10 poisonous plants that can ruin your trip to Russia

Sunburn is easier to prevent. Therefore, pediatricians recommend keeping children under 6 months old in sunny weather in the shade or covering their skin with clothes. Apply sunscreen to the skin of older children: the label should indicate that it protects against two types of ultraviolet radiation - UVA and UVB. Sun protection factor - SPF - should be between 30 and 50.

Verywellfamily: check-up from pediatricians

UpToDate: sunburn prevention and treatment

What not to do. The burn does not need to be disinfected. Just wash with soap and water. Do not use creams with painkillers, such as lidocaine, as they slow down the healing of the burn.

What to buy:
💊 Children's sunscreens with SPF 50 - 164 p
💊 Ointment with bacitrasin - from 357 p
💊 Wound outbringing on a non -woven basis - 727 r

insects

In children, a more reaction to insects of insects more more pronounced than in adults: swelling and redness may appear, which disappear within a few weeks. Due to severe itching, the child scratches the bite site and risks introducing an infection there.

What is possible. Chilled lotion with calamine or zinc can be used to soothe itching in children from birth. Reapply every hour throughout the day. In case of a pronounced reaction, when the lotion does not help, children from 2 years of age can smear the bite site with a cream with hydrocortisone 0.5 or 1%, for example, Afloderm. But you can use the drug no more than 2 times a day, in a thin layer and no longer than 3 days.

Mayo Clinic: First Aid for Insect Bites

Rassvet Clinic: Prevention and Treatment of Insect Bites

If an insect has bitten a child on the lip or eyelid, apply cold for 10-15 minutes until the swelling subsides. You can lubricate the bite site with hydrocortisone if the swelling does not subside.

What is not needed. After a bite, a plantain leaf, aloe juice or parsley gruel will not help. With such means, you can introduce an infection if they are not sterile, or enhance the reaction.

6 insects that can ruin a trip to Russia

What to buy:
💊 Cream with hydrocortisone - 32 R
💊 Afloderm cream - 442 R

Conjunctivitis, dryness and itching of the eyes

, in the first two days you can use eye drops.

What is possible. For small accumulations of pus, use antiseptic drops such as Okomistin. It can be dripped from birth.

If a child's eyelid does not close due to trauma or an insect bite, the eyes are watery and this interferes, instill artificial tear preparations, such as Systane. Drops moisturize the eyes, and lacrimation disappears.

Mayo Clinic: What parents need to know about conjunctivitis

What not to.

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