Deltamox CL

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Deltamox CL

Quick Facts

Property Description
Active ingredient Amoxicillin and Clavulanic acid
Form Oral Tablet, Oral Suspension
Pharmacological class beta-Lactam and beta-Lactamase Inhibitor Combination
Common use Resolution of bacterial infections
Origin Semisynthetic (Amoxicillin) and Fermentation-derived (Clavulanic acid)

What Type of Drug is Deltamox CL?

Deltamox CL is a combination prescription antibiotic administered via the oral route, designed specifically to treat infections caused by bacteria. It is formally classified as a beta-Lactam and beta-Lactamase Inhibitor Combination, representing a dual-component strategy against bacterial pathogens. The generic combination of Amoxicillin and Clavulanic acid is utilized for its efficacy against certain resistant strains.

Its fundamental therapeutic purpose is the resolution of bacterial infections within the body by eliminating the causative microorganisms. As an oral medication, it is available as a Tablet, a Chewable Tablet, or a powder for reconstitution into an Oral Suspension, which facilitates administration across different patient groups, including pediatric populations.


Composition: Amoxicillin and Clavulanic Acid

The composition of Deltamox CL relies on two distinct active ingredients: Amoxicillin and Clavulanic acid, typically supplied as Clavulanate potassium. Amoxicillin is a semisynthetic antibiotic that acts as the primary bactericidal agent. The second component, Clavulanic acid, is a fermentation-derived inhibitor that is non-antibacterial but critical to the drug’s effectiveness.

This fixed-dose pairing differentiates this medicine from single-agent penicillins. The inclusion of clavulanic acid prevents the hydrolytic inactivation of amoxicillin by beta-lactamase enzymes, supporting the drug’s broad-spectrum activity against targeted pathogens. This action characterizes the medicine as a combination product, where the Amoxicillin is protected from specific bacterial defense mechanisms.

What side effects are possible with Deltamox CL?

The official safety documentation for the Amoxicillin and Clavulanic acid combination, which includes Deltamox CL, formally classifies adverse reactions based on frequency and affected body system. This information is derived strictly from government regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).


Frequency and Common Adverse Reactions

The most frequently documented side effects relate to the gastrointestinal system. Regulatory documents classify diarrhea as a very common adverse reaction. Reactions listed as common include nausea, vomiting, and the occurrence of mucocutaneous candidiasis (fungal infection).

Uncommon effects involve mild central nervous system issues like dizziness and headache, as well as minor skin reactions such as urticaria (hives) and pruritus (itching).


Serious Adverse Reactions and Safety Constraints

Adverse reactions classified as rare or very rare require attention due to their potential seriousness. These include severe hypersensitivity reactions like anaphylaxis and rare severe skin conditions such as Stevens-Johnson syndrome (SJS). Effects on the hepatobiliary system, including hepatitis and cholestatic jaundice, are also documented as very rare, with onset sometimes delayed several weeks after treatment ends.

Specific safety constraints are noted for certain patient groups. The drug is contraindicated in individuals with a history of a severe immediate hypersensitivity reaction to any beta-lactam antibiotic. Furthermore, use is restricted in patients with a history of hepatic dysfunction associated with the previous use of this specific combination. Dose adjustments are formally required for patients with significant renal impairment.

Overdose and Emergency Response

Overdosage of Deltamox CL (Amoxicillin and Clavulanic acid) is officially documented to present with signs of gastrointestinal distress, including vomiting, diarrhea, abdominal pain, and nausea. Neurological effects are also noted, most severely as convulsions, or less commonly, as hyperactivity and drowsiness.

A primary concern documented in regulatory labeling is the risk of amoxicillin crystalluria, which involves the formation of crystals in the urine and can progress to severe outcomes like renal failure. Patients with impaired renal function are specifically identified as being at an increased risk of experiencing convulsions following an overdose.

When signs of a severe allergic reaction or other serious outcomes are observed, such as swelling or difficulty breathing, immediate medical attention must be sought. Official regulatory documents state that no specific antidote is known. Overdose management is defined as symptomatic and supportive treatment. Procedures such as haemodialysis can be used to remove the active ingredient from the circulation. To mitigate the crystalluria risk, it is required that adequate fluid intake and urinary output be maintained.

Therapeutic Uses of Deltamox CL

What Deltamox CL Treats: Main Uses and Benefits

Deltamox CL is a combination antibiotic commonly used to support the process of addressing bacterial infections and the overall symptom burden across therapeutic areas. This medication is relevant for infections of the ears, lungs, sinus, skin, and urinary tract. It is generally used during phases when symptoms become more noticeable, and may be part of symptomatic management when additional management of discomfort is required.

It is commonly used across conditions presenting with acute episodes. This includes managing conditions like bacterial rhinosinusitis, otitis media, certain pneumonias, skin and soft tissue infections, and infections resulting from bite wounds. It plays a role in managing symptoms that create noticeable functional strain.

“It is relevant for managing symptoms that interfere with daily comfort and require short-term symptomatic assistance.”


Supporting Symptom Management in Acute Respiratory and Systemic Illness

This medicine helps address symptom clusters that may become intense or disruptive. It is relevant for easing manifestations like a persistent cough, fever, localized pain, and inflammation. It may assist with maintaining functional stability by easing the impact of infection-related discomfort.

Quick Fact: Relief for Acute Discomfort
Symptom Type Targeted Areas
Systemic Imbalance Fever, malaise, fatigue
Functional Strain Cough, congestion, painful urination
Localized Discomfort Earache, sinus pressure, skin tenderness

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Deltamox CL eligibility is strictly defined by official regulatory criteria outlining who can and cannot use the medication. The medicine is contraindicated for patients with a documented history of serious hypersensitivity reactions to penicillins, other beta-lactam antibiotics, or a previous history of cholestatic jaundice or hepatic dysfunction associated with Amoxicillin/Clavulanate use. Use should be avoided in patients with infectious mononucleosis due to the risk of rash.

Population Eligibility Status Key Restriction (Regulatory Basis)
Severe Renal Impairment Restricted Must not receive the 875 mg Amoxicillin component dose.
Hepatic Impairment Conditional Use with caution; liver function monitoring is required.
Infants Conditional Use is restricted to the specific low-concentration oral suspension for those under 12 weeks of age.
Lactating Women Conditional Caution is advised as Amoxicillin is excreted in breast milk, potentially causing infant sensitization.
Phenylketonurics Avoid Must not use formulations (e.g., chewable tablets) that contain aspartame.

This structure establishes eligibility based on formal regulatory classifications, limiting use to populations for whom the risk profile is acceptable as defined by the official prescribing label.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes officially documented interaction patterns for Deltamox CL (Amoxicillin and Clavulanic acid) based on government regulatory documentation. The co-administration of probenecid is formally not recommended because this drug decreases the renal tubular secretion of the amoxicillin component. This interaction results in increased and prolonged concentrations of amoxicillin in the bloodstream.


Documented Pharmacodynamic and Exposure Interactions

When co-administered with oral anticoagulants, there is a pharmacodynamic interaction risk, which may lead to an increased prolongation of prothrombin time (elevated INR). Co-administration with allopurinol is associated with an increased incidence of skin rashes compared to amoxicillin use alone. Additionally, Deltamox CL may reduce the efficacy of combined oral contraceptives due to effects on intestinal flora, potentially leading to lower estrogen reabsorption. The combination is also associated with a reduction in the clearance of methotrexate.


Administration Timing and Special Populations

Administration of the medication must be taken at the start of a meal to enhance the absorption of the clavulanate potassium component, a required timing-based condition. For patients with impaired renal function, the excretion of amoxicillin is delayed, leading to altered systemic exposure. Furthermore, patients with evidence of hepatic impairment should have their hepatic function monitored due to documented reports of hepatic events. High concentrations of amoxicillin in the urine can cause false-positive reactions in non-enzymatic urine glucose tests.

Mechanism of Action

Irreversible Destruction of Bacterial Cell Walls

The primary mechanism involves Amoxicillin acting as a covalent inhibitor of Penicillin-Binding Proteins (PBPs), which are bacterial enzymes critical for cell wall construction. By permanently disabling these PBPs, the drug prevents the final cross-linking of peptidoglycan polymers, causing the cell wall structure to fail. This cascade results directly in the osmotic lysis (rupture and death) of the actively growing bacterial cell, achieving a bactericidal effect and resulting in a reduction of the bacterial population.


️ Enzymatic Protection and Susceptibility Expansion

The second mechanism, mediated by Clavulanic Acid, targets bacterial resistance mechanisms. Clavulanic Acid functions as an irreversible suicide inhibitor against bacterial beta-Lactamase enzymes, which are designed to hydrolyze and neutralize Amoxicillin. By sequestering and destroying these enzymes, Clavulanic Acid prevents the degradation of Amoxicillin. This protective synergy facilitates the primary bactericidal mechanism against many resistant strains, increasing the range of target pathogens susceptible to the drug's action.

Dosage and Administration Information

How to Use Deltamox CL

The usage of Deltamox CL (Amoxicillin and Clavulanate Potassium) follows specific administration principles. This medicine is for oral administration, and it is supplied in several forms, including tablets and powder for oral suspension.

Official Administration Guidelines

Instruction Principle of Use
Route and Form Administered exclusively via the oral route. Note that the various tablet and suspension strengths are not interchangeable due to differences in the amoxicillin-to-clavulanate ratio.
Meal Timing The dose should be taken at the start of a meal. This practice is specified to enhance the absorption of the clavulanate component and may assist in minimizing potential gastrointestinal intolerance.
Dosing Frequency The frequency is typically fixed, with regimens requiring administration either every 8 hours (three times daily) or every 12 hours (twice daily), depending on the specific tablet strength prescribed.
Treatment Duration The standard course of treatment generally lasts 7 to 10 days, although certain indications, such as acute otitis media, may require a 10-day duration.

Population and Procedural Rules

Specific protocols exist for certain patients. For pediatric patients under 40 kg, dosing is weight-based, calculated as mg/kg/day of the amoxicillin component. Furthermore, dose adjustments are required for adult patients with known renal impairment (kidney function below CrCl 30 mL/min), for whom the 875 mg tablet is generally not used.

The oral suspension must be reconstituted with water at the time of dispensing and shaken well before each use. If a dose is missed, it is directed to be taken as soon as it is remembered, unless it is almost time for the next scheduled dose, in which case the missed dose should be skipped to prevent taking two doses simultaneously.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Deltamox CL is a combination medication containing two active compounds: Amoxicillin, an antibiotic that prevents the formation of bacterial cell walls, and Clavulanic Acid, which protects Amoxicillin from degradation by bacterial enzymes (beta-lactamases). This combination is widely used to address infections caused by specific susceptible bacteria in the respiratory tract, ear, sinus, skin, and urinary tract. It is not effective against viral infections, such as the common cold.


Key Findings from Clinical Trials

Clinical trials have primarily focused on the effectiveness of this combination in achieving clinical and microbiological cure across various infection sites. The majority of research consists of randomized controlled trials (RCTs) comparing the drug to placebo or other established antibiotics.

Reported Efficacy Outcomes

  • Targeted Infections: Studies consistently assess the combination's ability to eliminate bacteria susceptible to the compound, reporting high rates of bacterial eradication in both adult and pediatric populations.
  • Duration of Therapy: Research supports that completing the full prescribed course is necessary to minimize the risk of bacterial resistance and relapse.

Reported Safety and Side Effects

As documented in clinical trials and post-marketing surveillance, the combination is generally associated with a manageable safety profile, though individual responses can vary.

System Common Adverse Events
Gastrointestinal Diarrhea, nausea, vomiting
Skin/Immune Mucocutaneous candidiasis (fungal infection)
Other Rash, allergic reactions (rare but serious)

The most frequently reported adverse events across trials are typically related to the gastrointestinal system. Discontinuation of treatment due to side effects is relatively uncommon.

Key Studies & References

  1. NICE Guideline NG139: Pneumonia (community-acquired): antimicrobial prescribing for adults. National Institute for Health and Care Excellence (NICE).

Frequently Asked Questions (FAQ)

Common questions about Deltamox CL (FAQ)

Q: Can Deltamox CL cause a temporary change in tooth color in children?

Official reports indicate that a change in tooth color, often appearing as yellow, gray, or brown, has been associated with this medication, primarily in children. This effect is usually temporary. Regulatory documents suggest that the discoloration has been observed to be reduced or eliminated following typical tooth brushing or professional dental cleaning.


Q: Can Deltamox CL potentially affect the kidneys?

While the drug is primarily eliminated by the kidneys, regulatory reports suggest that rare side effects can be linked to kidney function, such as bloody or cloudy urine or a significant decrease in the amount of urination. Official product information notes that dosage adjustments are formally outlined for patients who already have pre-existing reduced kidney function.


Q: Is developing a fever a cause for concern while taking Deltamox CL?

Fever, when combined with other symptoms like rash, chills, or persistent illness, is documented in regulatory safety reports as a potential sign of a rare but serious adverse reaction, such as a severe allergic or skin condition. A persistent or unexpected fever is a signal that generally warrants professional medical review, especially if it occurs alongside other signs.


Q: Are there any known long-term side effects that have been studied for Deltamox CL?

The medication is typically prescribed for short treatment periods. However, official safety documents note that certain effects on the liver, specifically a condition called cholestatic jaundice, can have a delayed onset, sometimes appearing several weeks after a patient has finished the course of therapy. Specific long-term studies on effects months or years after treatment are not typically included in the official product labeling.


Q: Can Deltamox CL cause a headache or dizziness?

Headache and dizziness are listed in official product information as known side effects, though they are classified as uncommon reactions. These effects are generally mild and related to the central nervous system.


Q: Does Deltamox CL pass into breast milk and what is the general guidance on breastfeeding?

The active components of Deltamox CL are known to be passed into breast milk. Official information advises caution for patients who are nursing, as the drug's components are present in breast milk and may lead to effects in the infant, such as sensitization (an allergic tendency), thrush (a fungal infection), or diarrhea.


Q: Are there any special considerations for using Deltamox CL in elderly patients?

The official guidance for geriatric use notes that elderly patients are statistically more likely to have reduced kidney function. Since this medicine is mainly processed and eliminated by the kidneys, dose adjustments may be necessary for these patients to account for age-related changes in renal function.


Q: What should a patient generally expect if their symptoms do not get better after a few days?

Regulatory guidance emphasizes that this antibiotic should only be used to treat infections strongly suspected to be bacterial. If a patient experiences no clinical improvement after a few days of treatment, the infection may not be susceptible to the drug, or it may be viral in nature. When clinical improvement does not occur, further medical evaluation is typically warranted to assess the reason and determine a subsequent course of action.


Q: What are the warning signs of a liver issue while taking Deltamox CL?

Safety documents list several signs that may indicate a liver problem. These include the development of dark urine, yellowing of the skin or the whites of the eyes (jaundice), light-colored stools, stomach pain, or persistent nausea and vomiting. Monitoring of liver function is typically required for patients with pre-existing hepatic impairment.


Q: What kind of diarrhea should prompt a patient to seek medical attention?

While mild diarrhea is a very common side effect, official warnings advise that severe, persistent, watery, or bloody diarrhea may indicate a serious condition called Clostridioides difficile-associated diarrhea (CDAD). This serious condition is generally known to require prompt medical evaluation.


Q: What is the risk of taking Deltamox CL while using blood thinners (anticoagulants)?

Regulatory information indicates a risk of pharmacodynamic interaction when Deltamox CL is co-administered with oral anticoagulants (blood thinners). This combination is associated with a prolongation of prothrombin time, a measure which could suggest an increased risk of bleeding.


Q: Is a mild stomach upset a typical expected side effect of this medicine?

Official clinical trial data classifies nausea and vomiting as common side effects of this medication. The regulatory product information specifically recommends taking the medicine at the start of a meal or snack to help minimize the potential for general gastrointestinal intolerance or upset.


Q: What is the difference in action between Deltamox CL and Amoxicillin taken alone?

The key difference is the addition of clavulanic acid, which is not an antibiotic itself but a protective agent. It works by neutralizing bacterial enzymes (beta-lactamases) that would otherwise break down amoxicillin. This protective action extends the range of bacterial strains the amoxicillin component can successfully eliminate, covering many bacteria resistant to amoxicillin alone.


Q: What happens if a patient starts to feel better quickly—is it still important to finish the full course?

Official guidance and clinical research consistently support that completing the entire prescribed course of therapy is warranted. Finishing the full course helps minimize the risk of developing drug-resistant bacteria and also reduces the likelihood of the infection recurring (relapse).


Q: Does the effectiveness of Deltamox CL vary based on the type of infection being treated?

Regulatory documentation indicates the drug is approved for a range of specific infections, such as those in the lower respiratory tract, ears, and skin. Its overall effectiveness is therefore defined by its ability to eliminate susceptible microorganisms within these specific clinical conditions, suggesting that efficacy is tied to the type and site of the infection being treated.


Q: Are there any ongoing studies or research themes regarding Deltamox CL and antibiotic resistance?

Regulatory bodies, such as the WHO and national health authorities, are continuously involved in monitoring and analyzing clinical data related to this drug. This ongoing research focuses on reviewing its effectiveness against evolving patterns of bacterial resistance, ensuring that dosing recommendations and minimum inhibitory concentrations remain appropriate.

How should Deltamox CL be stored and disposed of?

How to Store and Dispose of Deltamox CL

The required storage conditions for Deltamox CL (amoxicillin and clavulanate potassium) depend on the formulation.


Storage Requirements

  • Tablets (Dry): Store at Controlled Room Temperature, which is 20 C to 25 C (68 F to 77 F). The container must be kept tightly closed in the original packaging, protected from excess moisture and light.
  • Oral Suspension (Reconstituted Liquid): The liquid must be stored in a refrigerator at 2 C to 8 C (36 F to 46 F). The suspension must not be frozen and must be discarded after 10 days from the date of reconstitution.

Disposal and Child Safety

All forms must be kept out of the sight and reach of children. Unused or expired medicine should be disposed of via a drug take-back program. If a take-back option is unavailable, the medicine is not recommended for flushing and should be mixed with an undesirable substance, placed in a sealed container, and then discarded in the household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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