Ciclesonide Glenmark
Inhaled corticosteroid for asthma maintenance therapy
Quick Facts About Ciclesonide Glenmark
Key Takeaways
- Prodrug advantage: Ciclesonide is activated only in the lungs, reducing oral thrush and hoarseness risk compared to other inhaled corticosteroids
- Once-daily dosing: The convenient once-daily regimen improves adherence and simplifies asthma management for most patients
- Not a rescue inhaler: Ciclesonide Glenmark is for prevention only and must not be used to treat acute asthma attacks or sudden breathlessness
- Gradual onset: Full therapeutic benefit may take 1–2 weeks of regular use; do not stop treatment even when feeling well
- CYP3A4 interactions: Strong CYP3A4 inhibitors (ketoconazole, ritonavir) may increase systemic corticosteroid exposure and should be used with caution
What Is Ciclesonide Glenmark and What Is It Used For?
Ciclesonide Glenmark is an inhaled corticosteroid (ICS) containing ciclesonide 80 micrograms per actuation, prescribed for the regular maintenance treatment of persistent asthma in adults and adolescents aged 12 years and older. It works by reducing inflammation in the airways, helping to prevent asthma symptoms such as wheezing, chest tightness, and shortness of breath.
Ciclesonide belongs to the class of inhaled corticosteroids, which are the cornerstone of asthma management according to the Global Initiative for Asthma (GINA) guidelines. Unlike many other ICS medications, ciclesonide is formulated as a prodrug, meaning it is pharmacologically inactive when inhaled and only becomes active once it reaches the lungs. Esterase enzymes in the pulmonary tissue convert ciclesonide into its active metabolite, desisobutyryl-ciclesonide (des-CIC), which binds to glucocorticoid receptors with high affinity and exerts potent anti-inflammatory effects.
This unique prodrug mechanism offers a significant clinical advantage. Because the drug is not active in the mouth and throat, patients experience substantially lower rates of local oropharyngeal side effects such as oral candidiasis (thrush) and dysphonia (hoarseness) compared to conventional inhaled corticosteroids like fluticasone propionate or budesonide. Multiple randomized controlled trials and meta-analyses have confirmed this favorable local safety profile.
Ciclesonide Glenmark is manufactured by Glenmark Pharmaceuticals and contains the same active substance as the originator product. It is available as a metered-dose inhalation spray delivering 80 micrograms of ciclesonide per actuation. The medication is indicated for persistent asthma where the use of an inhaled corticosteroid is appropriate, typically for patients whose symptoms are not adequately controlled with short-acting bronchodilators alone.
According to the GINA 2024 stepwise approach, inhaled corticosteroids are recommended from Step 2 onwards as daily controller therapy. Ciclesonide at 80–160 mcg per day is classified as a low-dose ICS, making it suitable for patients with mild-to-moderate persistent asthma. The once-daily dosing regimen of ciclesonide is particularly advantageous for medication adherence, which remains one of the greatest challenges in chronic asthma management.
Ciclesonide Glenmark is a controller medication for long-term asthma management. It does not provide immediate relief from acute bronchoconstriction. Always carry a rapid-acting bronchodilator (such as salbutamol) for sudden symptom relief. If you find yourself needing your rescue inhaler more frequently, consult your healthcare provider as this may indicate worsening asthma control.
What Should You Know Before Taking Ciclesonide Glenmark?
Before starting Ciclesonide Glenmark, inform your doctor about all medical conditions, current medications, and whether you are pregnant, breastfeeding, or planning to become pregnant. Certain conditions and medications may affect how safely you can use this inhaler.
Contraindications
Ciclesonide Glenmark should not be used if you have a known hypersensitivity (allergy) to ciclesonide or any of the excipients contained in the formulation. Although rare, allergic reactions to inhaler components can occur and may manifest as skin rash, swelling, or breathing difficulties immediately after inhalation.
Ciclesonide is not indicated for the primary treatment of status asthmaticus or other acute episodes of asthma where intensive emergency measures are required. It is designed exclusively for prophylactic, maintenance therapy and should never replace a short-acting beta-2 agonist for immediate symptom relief during an acute exacerbation.
Warnings and Precautions
Several important precautions should be considered before and during treatment with Ciclesonide Glenmark:
- Adrenal suppression: Prolonged use of high doses of any inhaled corticosteroid can potentially suppress the hypothalamic-pituitary-adrenal (HPA) axis. This risk is lower with ciclesonide compared to some other ICS due to its prodrug design and high first-pass metabolism, but it should still be considered, particularly when transferring patients from oral corticosteroids to inhaled therapy.
- Switching from oral steroids: Patients being transferred from systemic (oral) corticosteroid therapy to inhaled ciclesonide require careful monitoring. The reduction in oral corticosteroid dose should be gradual, and patients should be observed for signs of adrenal insufficiency, including fatigue, weakness, nausea, and hypotension.
- Infections: Corticosteroids may suppress immune responses. Patients with active or quiescent pulmonary tuberculosis, untreated systemic fungal or bacterial infections, or ocular herpes simplex should use ciclesonide with caution and under close medical supervision.
- Growth effects in children: Inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. Regular monitoring of height is recommended for children and adolescents receiving prolonged treatment with any inhaled corticosteroid.
- Bone mineral density: Long-term use of inhaled corticosteroids at high doses may affect bone mineral density. Patients at risk of osteoporosis should be monitored and advised on calcium and vitamin D supplementation as appropriate.
- Paradoxical bronchospasm: As with other inhalation therapies, paradoxical bronchospasm (an immediate increase in wheezing after dosing) may occur. If this happens, discontinue Ciclesonide Glenmark immediately and initiate alternative therapy.
- Visual disturbances: Systemic and topical corticosteroid use may result in cataract formation or glaucoma. Patients who develop visual symptoms should be referred for ophthalmological evaluation.
Pregnancy and Breastfeeding
There is limited clinical data on the use of ciclesonide during pregnancy in humans. Animal reproductive studies have shown adverse effects at high doses, consistent with the pharmacological profile of corticosteroids. However, uncontrolled asthma during pregnancy poses significant risks to both the mother and fetus, including pre-eclampsia, premature birth, and low birth weight.
Current international guidelines, including GINA and the British Thoracic Society (BTS), recommend that pregnant women with asthma should continue their controller therapy, as the risks of uncontrolled asthma generally outweigh the potential risks of inhaled corticosteroid treatment. The decision to use Ciclesonide Glenmark during pregnancy should be made on an individual basis in consultation with a healthcare provider, weighing the potential benefits against the possible risks.
It is not known whether ciclesonide or its metabolites are excreted in human breast milk. Other inhaled corticosteroids have been detected in breast milk in low concentrations. A decision to continue or discontinue breastfeeding or therapy should be made considering the benefit of breastfeeding for the child and the benefit of therapy for the mother.
Do not abruptly discontinue Ciclesonide Glenmark without consulting your doctor. Sudden cessation of inhaled corticosteroid therapy can lead to a severe worsening of asthma symptoms. If a dose reduction is needed, it should be done gradually under medical supervision.
How Does Ciclesonide Glenmark Interact with Other Drugs?
Ciclesonide is primarily metabolized by the CYP3A4 enzyme system. Co-administration with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, and HIV protease inhibitors (ritonavir, nelfinavir) can significantly increase systemic exposure to the active metabolite des-CIC, potentially leading to increased corticosteroid side effects.
Understanding drug interactions with Ciclesonide Glenmark is important for ensuring both the safety and efficacy of treatment. Because ciclesonide and its active metabolite desisobutyryl-ciclesonide (des-CIC) are metabolized by cytochrome P450 3A4 (CYP3A4), any medication that significantly inhibits or induces this enzyme pathway may alter the pharmacokinetics of ciclesonide.
In clinical pharmacokinetic studies, co-administration of ciclesonide with ketoconazole (a potent CYP3A4 inhibitor) increased the systemic exposure (AUC) of the active metabolite des-CIC by approximately 3.6-fold. While this increase was statistically significant, cortisol levels remained within the normal range in most subjects. Nevertheless, such interactions warrant careful clinical consideration, especially during long-term concurrent use.
Major Interactions
| Drug | Category | Effect | Clinical Recommendation |
|---|---|---|---|
| Ketoconazole | Strong CYP3A4 inhibitor | ~3.6-fold increase in des-CIC exposure | Avoid combination or use with close monitoring |
| Itraconazole | Strong CYP3A4 inhibitor | Increased systemic corticosteroid exposure | Avoid prolonged co-administration |
| Ritonavir | HIV protease inhibitor / CYP3A4 inhibitor | Significantly increased corticosteroid levels | Avoid unless benefit outweighs risk; monitor for Cushing’s syndrome |
| Nelfinavir | HIV protease inhibitor / CYP3A4 inhibitor | Increased systemic corticosteroid exposure | Avoid combination; consider alternative ICS or antiretroviral |
| Cobicistat | Pharmacokinetic enhancer / CYP3A4 inhibitor | Increased systemic corticosteroid exposure | Avoid; use beclomethasone as alternative ICS if needed |
Minor Interactions
| Drug | Category | Effect | Clinical Recommendation |
|---|---|---|---|
| Erythromycin | Moderate CYP3A4 inhibitor | Modest increase in des-CIC levels | Generally safe; short courses unlikely to be significant |
| Diltiazem | Moderate CYP3A4 inhibitor | Mild increase in systemic exposure | Monitor for corticosteroid side effects with long-term use |
| Grapefruit juice | CYP3A4 inhibitor (dietary) | Minimal effect due to inhalation route | No significant clinical interaction expected |
It is important to note that ciclesonide has minimal systemic bioavailability due to extensive first-pass metabolism. The oral bioavailability of ciclesonide is less than 1%, meaning that any drug that is swallowed (rather than deposited in the lungs) is essentially inactivated. This pharmacokinetic property reduces the overall risk of drug interactions compared to inhaled corticosteroids with higher oral bioavailability.
Always inform your healthcare provider and pharmacist about all medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins, to ensure safe concurrent use with Ciclesonide Glenmark.
What Is the Correct Dosage of Ciclesonide Glenmark?
The recommended dose of Ciclesonide Glenmark for adults and adolescents (12 years and older) is 160 micrograms once daily (2 puffs of 80 mcg), administered in the evening. The dose may be adjusted by your doctor based on disease severity and individual response, and reduced to the minimum effective dose once asthma is controlled.
Dosing of Ciclesonide Glenmark should be individualized according to the severity of the patient's asthma and their previous maintenance therapy. The goal is to achieve and maintain asthma control at the lowest effective dose, in accordance with GINA guidelines. Once asthma stability has been achieved, the dose should be titrated to the minimum dose that maintains effective symptom control.
Adults and Adolescents (12 years and older)
Standard Dosing
Recommended dose: 160 mcg once daily (2 puffs of 80 mcg)
Maximum dose: 320 mcg once daily (4 puffs of 80 mcg) or divided into 160 mcg twice daily
Timing: Preferably in the evening
Some patients may achieve adequate control with 80 mcg once daily, particularly those stepping down from higher doses after achieving stable asthma control. Clinical studies have demonstrated that once-daily dosing of ciclesonide is as effective as twice-daily dosing for maintaining asthma control.
Children (under 12 years)
Pediatric Dosing
Ciclesonide Glenmark 80 mcg inhalation spray is generally not recommended for children under 12 years of age, as there is insufficient data to establish its safety and efficacy in this age group. Some formulations of ciclesonide may be approved for children aged 6–11 years in certain countries at a dose of 80 mcg once daily, but this should only be initiated under specialist guidance.
For younger children requiring inhaled corticosteroid therapy, alternative ICS options with established pediatric dosing should be considered, such as budesonide or fluticasone propionate.
Elderly Patients
Geriatric Dosing
No dose adjustment is necessary for elderly patients. However, older adults may be more susceptible to the systemic effects of corticosteroids and should be monitored for bone density changes, cataract formation, and adrenal suppression, particularly when using higher doses or multiple corticosteroid-containing products concurrently.
| Patient Group | Starting Dose | Maintenance Dose | Maximum Dose | Frequency |
|---|---|---|---|---|
| Adults (18+) | 160 mcg/day | 80–160 mcg/day | 320 mcg/day | Once daily (evening) |
| Adolescents (12–17) | 160 mcg/day | 80–160 mcg/day | 320 mcg/day | Once daily (evening) |
| Children (<12) | Not recommended | N/A | N/A | N/A |
| Elderly | 160 mcg/day | 80–160 mcg/day | 320 mcg/day | Once daily (evening) |
Missed Dose
If you forget to take a dose of Ciclesonide Glenmark, take it as soon as you remember. However, if it is nearly time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for a missed one. Consistent daily use is essential for optimal asthma control, so consider setting a daily reminder to help maintain your dosing schedule.
Overdose
Acute overdose with inhaled ciclesonide is unlikely to cause immediate clinical problems. In clinical studies, single doses up to 2,880 mcg have been administered without significant adverse effects. Chronic use of excessive doses may lead to systemic corticosteroid effects, including HPA axis suppression, Cushing’s syndrome features (moon face, central obesity, skin thinning), and reduced bone mineral density.
If long-term overdosing is suspected, adrenal function should be monitored and the dose should be gradually reduced to the minimum effective level. There is no specific antidote for ciclesonide overdose. In case of suspected overdose, seek medical advice and continue treatment as clinically indicated, reducing the dose gradually rather than stopping abruptly.
What Are the Side Effects of Ciclesonide Glenmark?
Ciclesonide Glenmark is generally well-tolerated, particularly regarding local oropharyngeal effects. The most common side effects include headache and nasopharyngitis. Serious side effects such as adrenal suppression are rare and typically associated only with high-dose, long-term use. Ciclesonide's prodrug design confers a more favorable local side effect profile compared to many other inhaled corticosteroids.
The side effect profile of ciclesonide has been extensively studied in clinical trials involving thousands of patients. One of the key advantages of ciclesonide over other inhaled corticosteroids is its significantly lower incidence of local oropharyngeal side effects, which is attributed to its prodrug formulation. Because the parent compound is pharmacologically inactive, drug deposited in the oropharynx does not exert local corticosteroid effects, and it is subsequently swallowed and undergoes extensive first-pass hepatic metabolism.
A large-scale meta-analysis published in the Journal of Allergy and Clinical Immunology confirmed that ciclesonide was associated with a significantly lower incidence of oral candidiasis and dysphonia compared to fluticasone propionate and budesonide at equivalent anti-inflammatory doses. This is a clinically meaningful difference, as oropharyngeal side effects are among the most common reasons for patient non-adherence to inhaled corticosteroid therapy.
Common (1 in 10 to 1 in 100 patients)
- Headache
- Nasopharyngitis (common cold symptoms, runny nose)
- Unpleasant taste (dysgeusia)
- Back pain
Uncommon (1 in 100 to 1 in 1,000 patients)
- Oral candidiasis (thrush)
- Hoarseness (dysphonia)
- Cough after inhalation
- Nausea
- Dry or sore throat
- Influenza-like symptoms
- Bronchitis
Rare (less than 1 in 1,000 patients)
- Paradoxical bronchospasm
- Hypersensitivity reactions (rash, urticaria, angioedema)
- Adrenal suppression (with high-dose, prolonged use)
- Growth retardation in children (with prolonged use)
- Decreased bone mineral density
- Glaucoma or posterior subcapsular cataracts
- Behavioral changes (anxiety, sleep disturbances, hyperactivity) — more common in children
Contact your doctor or seek emergency medical help immediately if you experience: severe breathing difficulties or worsening wheezing directly after using the inhaler (paradoxical bronchospasm), swelling of the face, lips, tongue, or throat (angioedema), severe skin rash or hives, signs of adrenal crisis (extreme fatigue, severe weakness, confusion, very low blood pressure), or signs of a severe allergic reaction.
Patients should be advised that the long-term systemic effects of inhaled corticosteroids, while rare at recommended doses, may include effects on bone metabolism, adrenal function, ocular health, and growth in children. Regular follow-up appointments with a healthcare provider are recommended to monitor for these potential effects, especially in patients using higher doses or multiple corticosteroid preparations.
How Should You Store Ciclesonide Glenmark?
Store Ciclesonide Glenmark at room temperature below 30°C (86°F). Do not freeze. Keep the inhaler away from direct sunlight and heat. The canister is pressurized and should not be punctured, broken, or incinerated, even when apparently empty.
Proper storage of Ciclesonide Glenmark is essential to maintain the medication's stability, potency, and safety throughout its shelf life. Incorrect storage conditions can degrade the active ingredient, alter the spray characteristics of the metered-dose inhaler, or compromise the integrity of the pressurized canister.
- Temperature: Store at room temperature, not exceeding 30°C (86°F). Avoid exposure to extreme heat or cold. Do not store in a refrigerator or freezer.
- Light protection: Keep the inhaler in its original packaging until use to protect from direct sunlight and excessive light exposure.
- Moisture: Store in a dry place. Do not expose the inhaler to high humidity environments such as bathrooms.
- Canister integrity: The inhaler contains a pressurized propellant. Do not puncture, crush, or incinerate the canister, even when it appears empty. Do not expose to temperatures above 50°C (122°F).
- Keep out of reach of children: Store the medication where children cannot access it.
- Expiry date: Do not use Ciclesonide Glenmark after the expiry date printed on the canister and outer packaging. The expiry date refers to the last day of that month.
- Disposal: Do not dispose of medications via wastewater or household waste. Ask your pharmacist about appropriate disposal methods for unused or expired medications to help protect the environment.
After first opening, the inhaler should be used within the timeframe specified by the manufacturer, typically within 3 months. Before first use and when the inhaler has not been used for more than 7 days, prime the device by actuating it into the air (away from the face) at least three times to ensure a consistent dose is delivered with each subsequent use.
What Does Ciclesonide Glenmark Contain?
Each actuation of Ciclesonide Glenmark delivers 80 micrograms of ciclesonide as the active substance. The formulation also contains the propellant norflurane (HFA-134a) and ethanol as excipients.
Ciclesonide Glenmark is formulated as a solution-based pressurized metered-dose inhaler (pMDI). Unlike suspension-based inhalers, solution formulations produce a finer, more uniform aerosol with smaller particle sizes, which can improve lung deposition and reduce oropharyngeal impaction. This formulation characteristic complements the prodrug design of ciclesonide in minimizing local side effects.
The active substance, ciclesonide, is a synthetic corticosteroid with the chemical name pregna-1,4-diene-3,20-dione, 16,17-[cyclohexylmethylenebis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-, (11β,16α). Its molecular formula is C32H44O7 and it has a molecular weight of 540.7 g/mol.
Excipients:
- Norflurane (HFA-134a): The propellant used to generate the aerosol spray. HFA-134a is a non-CFC (chlorofluorocarbon-free) propellant that is environmentally safer than older CFC propellants. It has a lower global warming potential than some older propellant alternatives.
- Ethanol (anhydrous): Used as a co-solvent to maintain ciclesonide in solution within the HFA propellant. The amount of ethanol in each actuation is very small and clinically insignificant.
The inhaler device consists of an aluminum canister fitted with a metering valve, enclosed in a plastic actuator body with an integrated mouthpiece. Each canister typically contains 60 or 120 metered doses, depending on the pack size.
Frequently Asked Questions About Ciclesonide Glenmark
Ciclesonide Glenmark is used for the regular maintenance treatment of persistent asthma in adults and adolescents aged 12 years and older. It is an inhaled corticosteroid that reduces airway inflammation and helps prevent asthma symptoms including wheezing, breathlessness, chest tightness, and coughing. It is not a rescue inhaler and should not be used for immediate relief of acute asthma attacks.
Ciclesonide is unique among inhaled corticosteroids because it is a prodrug. It remains inactive until it reaches the lungs, where enzymes convert it to its active form (des-CIC). This means that any drug deposited in the mouth and throat remains inactive and does not cause local side effects. This results in significantly lower rates of oral thrush and hoarseness compared to other ICS medications like budesonide and fluticasone.
There is limited data on ciclesonide use during pregnancy. International guidelines recommend that pregnant women continue their asthma controller therapy because uncontrolled asthma poses significant risks to both mother and baby. Discuss with your doctor, who can weigh the benefits of asthma control against potential risks and recommend the most appropriate treatment for your individual situation.
Because ciclesonide is a prodrug that is inactive in the mouth, the risk of oral candidiasis (thrush) is much lower than with other inhaled corticosteroids. While mouth rinsing after use is generally less critical with ciclesonide than with other ICS, it is still considered good practice to rinse your mouth and spit out the water after inhalation to minimize any residual drug in the oropharynx.
Some patients may notice improvement in their asthma symptoms within 24 hours of starting treatment, but the full anti-inflammatory benefit of ciclesonide typically develops over 1 to 2 weeks of regular daily use. It is important to continue using the inhaler every day as prescribed, even when you feel well, to maintain optimal asthma control. If symptoms do not improve after 2 weeks, consult your healthcare provider.
All information is based on international medical guidelines and peer-reviewed research: GINA 2024 Global Strategy for Asthma Management and Prevention, EMA Summary of Product Characteristics for ciclesonide, FDA Prescribing Information, Cochrane systematic reviews on inhaled corticosteroids for asthma, and the British National Formulary (BNF). All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomized controlled trials.
References
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. Updated 2024. Available at: ginasthma.org/gina-reports/
- European Medicines Agency (EMA). Summary of Product Characteristics: Ciclesonide. Last updated 2024.
- U.S. Food and Drug Administration (FDA). Alvesco (ciclesonide) Prescribing Information. Reference ID: 4835677.
- Dahl R, et al. Ciclesonide, a novel inhaled corticosteroid prodrug, does not suppress hypothalamic-pituitary-adrenal axis function at clinically relevant doses. Chest. 2006;129(6):1616-1622. doi:10.1378/chest.129.6.1616
- Nave R, et al. Clinical pharmacokinetic properties of the inhaled corticosteroid ciclesonide. Clin Pharmacokinet. 2007;46(4):273-296. doi:10.2165/00003088-200746040-00001
- Derendorf H, et al. Ciclesonide: a pro-drug designed to minimize oropharyngeal deposition and systemic side effects in inhaled corticosteroid therapy. J Allergy Clin Immunol. 2006;117(S2):S218. doi:10.1016/j.jaci.2005.12.856
- British National Formulary (BNF). Ciclesonide. NICE. Last updated 2024. Available at: bnf.nice.org.uk
- Cochrane Database of Systematic Reviews. Inhaled corticosteroids versus placebo for asthma. 2023.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023.
- Bateman ED, et al. Efficacy and safety of ciclesonide once daily in asthma. Respir Med. 2006;100(8):1297-1306. doi:10.1016/j.rmed.2006.04.024
About Our Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising board-certified physicians specializing in pulmonology, pharmacology, and respiratory medicine. Our team follows evidence-based methodology using the GRADE framework, and all content is reviewed against current international guidelines including GINA 2024, EMA, FDA, and BNF recommendations.
Evidence-Based Methodology
All medical claims are supported by peer-reviewed research and international guidelines. We use Evidence Level 1A (systematic reviews and meta-analyses of RCTs) as our primary standard. Content is independently reviewed with no pharmaceutical sponsorship.
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This article is reviewed and updated regularly to reflect the latest clinical evidence and guideline changes. Last medical review: . Next scheduled review: July 2026.