Kala

Quick links to important sections

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

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 Kala

Quick Facts

Property Description
Active ingredient Drospirenone (DRSP) and Ethinyl Estradiol (EE)
Form Oral Tablet (Monophasic regimen)
Pharmacological class Hormonal Contraceptive (Estrogen-Progestin Combination)
Common use Contraception (Prevention of pregnancy)
Origin Synthetic Hormones

What Type of Medicine is Kala?

Kala is formally classified as a combination oral contraceptive (COC), a prescription-only medication administered in the form of an oral tablet. This formulation belongs to the high-level pharmacological class of hormonal contraceptives, which is the category for all medications utilizing sex hormone derivatives. This established classification is clinically recognized for its effectiveness in systemic fertility regulation.

Kala's Composition: Synthetic Hormones and Origin

The medication contains a fixed-dose combination of two active ingredients: Drospirenone (DRSP), a synthetic progestin, and Ethinyl Estradiol (EE), a synthetic estrogen. Both compounds are chemically synthesized derivatives. Drospirenone is a fourth-generation progestin that offers unique anti-mineralocorticoid properties, which differentiate its pharmacological profile from earlier progestin compounds. The combination is a monophasic formulation, providing a consistent daily hormonal level throughout the cycle. This combination approach is widely utilized and medically accepted for preventing unintended pregnancy.

General Purpose: Preventing Pregnancy

The essential, singular purpose of using Kala is contraception, which represents its typical, neutral use scenario for women of reproductive potential. This goal is achieved because the synthetic hormones work primarily by causing ovulation inhibition and concurrently altering the cervical mucus and endometrial lining. This systemic hormonal regulation is the standard mechanism by which combination oral contraceptives provide reliable pregnancy prevention.

Regulatory References

  1. NIH StatPearls on OCPs

What side effects are possible with Kala?

Possible side effects and safety information for Kala (KPI-012)

Adverse Reaction Scope

The investigational drug KPI-012 (Kala) is a topical ophthalmic solution developed for Persistent Corneal Epithelial Defect (PCED). The official safety information is derived from clinical trials and has not yet been established through a final regulatory approval (such as an FDA Prescribing Information or EMA Summary of Product Characteristics) which typically documents comprehensive side effect profiles and frequency classifications.

Key findings from the completed Phase 2b CHASE clinical trial, which involved 79 randomized patients, indicated that the drug was well-tolerated. Specifically, the trial reported no treatment-related serious adverse events (SAEs) across the two tested doses (3 U/mL and 1 U/mL) administered over 56 days.

Adverse Reaction Category Status in Clinical Trials (KPI-012)
Serious Adverse Reactions None reported to be treatment-related in the Phase 2b CHASE trial.
Frequency Classification Not formally classified (Investigational Status).
System-Organ Class Safety events are primarily ocular, consistent with a topical eye medication.

Safety Classifications and Considerations

The drug received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of PCED, recognizing the high unmet medical need and facilitating expedited review processes.

  • Population-specific safety considerations: Safety data is limited to patients with PCED or those with prior permanent vision loss and is not generalizable to the broader population. Trial exclusion criteria included active ocular infection, severe corneal burns, and recent ocular surgery, which restrict the application of the safety data.
  • Dose- or exposure-related patterns: The favorable safety profile was observed with both the high dose (3 U/mL) and low dose (1 U/mL) administered four times daily for 56 days.
  • Safety-related restrictions: The drug is investigational, and its use is restricted to participants within controlled clinical studies.

Summary

Based on regulatory-cited clinical data, KPI-012 was consistently well-tolerated and demonstrated a favorable safety profile across the Phase 1b and Phase 2b trials for PCED. The most critical safety assessment, the incidence of serious adverse events, showed none were treatment-related. This establishes a baseline of low risk for acute or serious complications within the studied population and dose range, though the overall risk profile remains incomplete because the clinical program has been discontinued.

Overdose and Emergency Response

Overdose and When to Seek Help

The official prescribing information for Kala (Drospirenone and Ethinyl Estradiol) outlines the documented physiological manifestations and mandated emergency actions that must be taken if an overdose is suspected.

Overdose Scope: Manifestations and Action

Category Official Regulatory Documentation
Documented Manifestations The clinical signs listed in regulatory documents following ingestion of a large dose include nausea and vomiting (gastrointestinal effects), and vaginal bleeding (a form of withdrawal bleeding).
Emergency-Response Statement Authorities explicitly state that individuals must seek emergency medical attention or call a Poison Control Center if an overdose is suspected or has occurred.

Overdose Classification and Management

Category Official Regulatory Documentation
Severity Classification An acute overdose of this type of hormonal contraceptive is generally classified as not likely to be life-threatening based on regulatory assessment.
Official Management Treatment is limited to symptomatic and supportive measures, as the official prescribing information states that no specific antidote is known for this formulation.
Population Notes No population-specific overdose considerations are defined in the acute overdose section of the official labeling.

The regulatory documentation defines the expected overdose presentation through a consistent symptom cluster, which primarily involves gastrointestinal and reproductive effects. Despite the low acute toxicity classification, regulatory guidance strictly mandates that immediate medical help must be sought for professional guidance regardless of the severity of the initial presentation to ensure appropriate oversight.

Therapeutic Uses of Kala

What Kala Treats: Main Uses and Benefits

Kala is primarily used for pregnancy prevention for women of reproductive potential. Beyond this fundamental use, the medication is commonly used to help with conditions involving episodic or fluctuating manifestations, applied in addressing three key areas: Premenstrual Dysphoric Disorder (PMDD), moderate acne vulgaris, and menstrual cycle symptoms like painful periods (dysmenorrhea) and irregularity.

The formulation is relevant when supportive symptom management is appropriate for symptoms that create noticeable physiological strain. It contributes to easing the overall symptom load during the pre-menstrual phase, helping with symptoms that interfere with daily functioning, such as profound anxiety, affective swings, and cyclical bloating. The medication may assist with maintaining a sense of stability when symptoms are more noticeable, supporting patients during difficult episodes, and contributing to improved comfort during periods of heightened symptoms.


Quick Fact: Therapeutic Focus
Primary Indication: Pregnancy prevention
Co-Indications: PMDD, Moderate Acne Vulgaris
Symptom Benefit: Assists with painful periods and cyclical bloating

Regulatory References

  1. NIH MedlinePlus overview of this medication

Eligibility and Restrictions for Use

Who can and cannot use Kala?

Eligibility for Kala (Drospirenone/Ethinyl Estradiol) is strictly defined by regulatory documents, primarily excluding populations with certain medical conditions or heightened health risks.

Contraindicated Populations (Must Not Use)

Condition/Status Regulatory Status
Smoking and over 35 years old Contraindicated
Known or suspected pregnancy Contraindicated
History of thrombotic disorders (DVT, PE, stroke, MI) Contraindicated
Breast or other hormone-sensitive cancers Contraindicated

Condition-Specific Ineligibility

The medicine is also contraindicated in females with renal impairment, hepatic impairment (liver tumors or disease), and adrenal insufficiency due to the drospirenone component’s effect on potassium [1.1]. It must not be used by those with uncontrolled hypertension or certain severe migraine types.

Age and Reproductive Status Rules

Use is not indicated for females before menarche (the start of menstruation) or for women in the geriatric population. For non-breastfeeding women, the start of use is restricted to no earlier than four weeks after delivery. Use is not recommended while breastfeeding [4.2].

What should I know about interactions with other medicines?

The interaction profile for this medicine is characterized by pharmacokinetic effects that alter hormone exposure and pharmacodynamic effects that influence potassium levels. Co-administration is formally contraindicated with specific combination drug regimens used for Hepatitis C virus (HCV), such as those containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the documented potential for elevated liver enzymes. The hormonal medication must be discontinued before starting these HCV treatments and can be restarted approximately two weeks following completion of the antiviral regimen.

Metabolic interactions primarily involve the CYP3A4 enzyme. Strong enzyme inducers, including certain anticonvulsants or the herbal product St. John's Wort, can decrease the plasma concentrations of the contraceptive hormones, potentially reducing effectiveness. Conversely, strong CYP3A4 inhibitors, such as ketoconazole or clarithromycin, may lead to increased systemic exposure of the hormones.

A separate interaction category involves the progestin drospirenone, which has anti-mineralocorticoid activity. This action creates an additive risk of hyperkalemia when combined with other potassium-elevating agents, including NSAIDs, ACE inhibitors, Angiotensin-II Receptor Antagonists, and potassium-sparing diuretics. This medicine is also formally contraindicated in patient populations predisposed to hyperkalemia, such as those with renal impairment, hepatic impairment, or adrenal insufficiency. Grapefruit juice may also affect the plasma concentration of the estrogen component.

Mechanism of Action

Stimulating Tissue Repair and Regeneration

This domain describes how Kala acts as an agonist for specific growth factor receptors and provides Extracellular Matrix proteins to actively support the Cell Proliferation and Differentiation Signaling pathways. The activation of these molecular steps influences cellular proliferation and matrix synthesis, promoting tissue remodeling and structural organization.


Modulating Local Immune and Inflammatory Response

Kala contains components that function as modulators of the Acute/Chronic Inflammatory Cascade by downregulating pro-inflammatory cytokine signaling. This action modulates the local Immune/Inflammatory Response, resulting in the downregulation of vascular permeability and immune cell infiltration.


Supporting Cellular Health and Neuroprotection

This mechanism involves supporting Neurotrophic Signaling and reducing the effects of reactive oxygen species to manage oxidative stress at the cellular level. This mechanism helps to maintain cellular integrity by reducing oxidative stress and contributes to the regulation of cellular survival pathways.

Dosage and Administration Information

How to Use Kala

Kala is administered via the oral route as a fixed-dose combination tablet, following a continuous, 28-day cyclic regimen. The treatment follows a standardized administrative protocol for the duration of the treatment course.


Administration Scope

Entity Description
Route of administration Oral route, requiring the tablet to be swallowed with liquid.
Dosing schedule One tablet daily in a 28-day cycle, consisting of 24 active tablets (3 mg Drospirenone / 0.02 mg Ethinyl Estradiol) followed by 4 inert (placebo) tablets.
Timing in relation to meals (if applicable) May be taken without regard to meals. Administration is typically recommended preferably after the evening meal or at bedtime.
Age-group administration rules Not indicated for use prior to menarche. Post-pubertal adolescents (14 years of age) follow the standard adult regimen.
Missed-dose rules Specific protocols govern action based on the number of missed tablets and the week of the cycle. Failure to follow these procedures may necessitate the temporary use of an additional non-hormonal contraceptive method.
Special procedural conditions Tablets must be consumed in the exact sequential order directed on the blister pack, and a new pack must be commenced immediately following the last placebo tablet of the previous cycle.

Instruction Classifications (High-Level)

Classification Description
Administration method type Oral.
Frequency pattern Daily (continuous administration in 28-day cycles).
Standardized Protocol Consistent daily timing and sequential intake.
Use-context constraints Sequential intake, consistent daily timing, and specific protocols for regimen initiation and missed doses.

Resulting Procedural Structure

Step sequence:

  • Take one tablet daily, swallow with liquid, and ensure intake occurs at the same time every day.
  • Consume tablets in the exact sequence directed on the blister pack for 28 consecutive days.
  • The cycle requires 24 active tablets followed by 4 inert tablets, with immediate commencement of a new pack upon completion of the previous one.
  • Follow the procedures for missed active doses, which may require the use of an additional non-hormonal contraceptive method depending on the timing of the missed tablet(s).

Connection to the overall use protocol:

These instructions structure the use of Kala as a 28-day cyclic regimen demanding continuous, time-sensitive oral administration of a fixed dose. The sequential intake of active and placebo tablets, coupled with protocols for starting the regimen and managing missed doses, defines the administrative framework required to adhere to the drug's usage pattern.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Kala

Evidence for Use in Pregnancy Prevention (Contraception)

Research on Kala has primarily focused on the study of fertility regulation. The research base is formed by large-scale, international prospective clinical trials, which track women of reproductive potential over several treatment cycles. These trials are complemented by extensive post-marketing surveillance programs that gather information on long-world use and adherence. Studies monitored the rate of pregnancy incidence over defined time intervals, typically calculated using the Pearl Index. Research also examined menstrual pattern regularity, including patterns observed in the frequency of unscheduled bleeding. Study results reflect the specific conditions under which they were conducted, and research cannot determine whether an individual will respond similarly, as personal adherence and health factors can vary widely.

Evidence for Use in Premenstrual Dysphoric Disorder (PMDD)

Studies exploring symptom patterns associated with Premenstrual Dysphoric Disorder (PMDD) were primarily conducted through large, randomized, double-blind, placebo-controlled trials (RCTs). Research examined outcomes related to physical discomfort and mood and behavioral changes over several menstrual cycles. The findings described the symptom patterns measured in the observed populations, and studies monitored changes in daily functioning using standardized rating scales specifically designed for this condition.

The key RCTs typically used short-term follow-up durations, with primary outcomes measured after only three to six treatment cycles. This means long-term effects are not fully established, and there is limited information for long-term outcomes regarding the durability of symptom patterns over extended periods. Comparative evidence against other PMDD treatments remains an area for further study.

What Remains Under Research and Uncertain

While the evidence base is large for the primary indication of contraception, a major research limitation is that the follow-up durations were limited in the core trials for PMDD and acne, leaving long-term effects not fully established. Additionally, comparative evidence is often lacking for direct head-to-head comparisons of this formulation against all available alternative therapies for PMDD or acne.

Key Studies & References

  1. Drospirenone and Ethinyl Estradiol Oral Contraceptives - MedlinePlus Drug Information
  2. Contraception - NIH Bookshelf [For general mechanism and classification]
  3. Efficacy of drospirenone and ethinyl estradiol in treating acne vulgaris: a randomized, controlled trial [Representative acne trial supporting indication]
  4. Evaluation of a continuous regimen of drospirenone and ethinyl estradiol in the treatment of premenstrual dysphoric disorder [Representative PMDD trial supporting indication]

Frequently Asked Questions (FAQ)

Common questions about Kala (FAQ)


Q: How is Kala different from other similar treatments I've heard about?

Kala is classified as a combination oral contraceptive using synthetic hormones. According to the official product information, its progestin component, drospirenone, is unique because it possesses anti-mineralocorticoid properties. This feature distinguishes its pharmacological profile within the class of oral contraceptives.


Q: Are there any common foods or drinks I should avoid while taking Kala?

Regulatory information advises that consuming grapefruit or grapefruit juice may affect how your body absorbs the medication's estrogen component. Aside from grapefruit, there are no other common foods or drinks consistently listed in the official product warnings that are required to be strictly avoided.


Q: Can I take Kala if I also take supplements like vitamins or herbal remedies?

Official guidance indicates that patients should inform their healthcare provider about all prescription drugs, over-the-counter medicines, vitamins, and herbal products they are taking. Sharing this information helps your healthcare provider check for potential interactions, such as with St. John's Wort, which can reduce the medication's effectiveness.


Q: Have there been many long-term studies published about Kala?

Research evidence for Kala includes large-scale clinical trials tracking effectiveness for contraception. However, official documents note that the core trials for specific non-contraceptive indications, like PMDD, primarily used short-term follow-up durations, meaning long-term effects are not fully established.


Q: Is Kala approved for use in children or adolescents?

The medication is officially not indicated for use before a female begins menstruation (menarche). Post-menarche adolescents are described in regulatory documents as following the same standard adult administration regimen.


Q: Why is it important to share my full list of medicines before starting Kala?

It is important to share a full list of medicines because co-administration with other drugs may alter the blood levels of the contraceptive hormones, potentially reducing its effectiveness. It can also increase the risk of serious side effects, such as dangerous levels of potassium (hyperkalemia) or blood clots.


Q: What is the general success rate described in the research for Kala?

Efficacy in preventing pregnancy is typically measured in clinical trials using the Pearl Index, which calculates the rate of pregnancy incidence. Studies and official information indicate that when the medication is taken correctly and consistently, it is considered highly effective.


Q: Do I need to change my diet while I am using Kala?

According to regulatory documents, there is no official requirement for a complete change in diet while using this medication. However, official information does mention an interaction with grapefruit and grapefruit juice, which can increase the level of the estrogen component in the body.


Q: What is the difference between Kala and a placebo, based on clinical trials?

Clinical trials were conducted using a placebo for the treatment of Premenstrual Dysphoric Disorder (PMDD). Studies indicated that the medication was statistically superior to the placebo in reducing the measured symptoms associated with this condition.


Q: Does Kala have any known effects on mood or anxiety?

Official safety information includes worsening mood and feelings of depression as potential side effects. Conversely, the medication is also indicated for the relief of PMDD symptoms, which include mood swings and anxiety, as demonstrated in clinical studies.


Q: Is Kala considered a long-term treatment or a short-term one?

The medication is intended for continuous, daily administration in a 28-day cyclic regimen for contraception and other approved indications. Its use is typically maintained for the duration that contraception or symptom management is desired and medically appropriate.


Q: Does Kala cause weight gain or weight loss?

According to official product labeling, weight gain is listed as one of the most common adverse reactions reported by patients in clinical trials for this medication.


Q: How long does it typically take to start feeling the effects of Kala?

When starting the medication, official patient information advises using a backup non-hormonal contraceptive method for the first 7 days of the first cycle. This guidance is provided to help ensure effective pregnancy prevention.


Q: Can Kala affect my sleep patterns?

Potential side effects include symptoms that may affect sleep patterns, such as difficulty concentrating and unusual tiredness or weakness. A change in sleep is also listed in official documents as a symptom of PMDD that the drug is indicated to treat.


Q: Is it normal to feel a bit tired when first starting Kala?

Unusual tiredness or weakness is listed in regulatory documents as a possible, though less common, side effect of the medication. This is based on adverse event reporting from clinical studies.


Q: What is the longest period of time someone is approved to use Kala?

The medication is approved for long-term use for contraception as long as it remains medically appropriate and the patient continues to meet eligibility criteria. Regulatory documents state that the risks of some serious side effects, such as blood clots, may increase with long-term use.


Q: What should I do if the side effects of Kala seem to get worse over time?

Official patient information indicates that patients should seek the immediate attention of a healthcare provider if experiencing any serious side effects, such as signs of a blood clot (e.g., chest pain, shortness of breath) or a sudden, severe headache.


Q: Can Kala make me feel dizzy or affect my ability to drive?

While not listed as a common effect, dizziness and confusion are symptoms that official documents list as part of the signs of a serious condition, such as a stroke. Symptoms such as these should be reported to a healthcare provider immediately.


Q: What are the most commonly reported side effects of Kala?

The most common adverse reactions reported in clinical trials include nausea, headache, breast pain or tenderness, weight gain, and bleeding irregularities (such as spotting or bleeding between periods).


Q: Does taking Kala affect the results of any common lab tests?

Yes, official documents note the possibility of the medication interfering with the laboratory screening for primary aldosteronism, a condition related to high blood pressure. It may also alter the results of blood tests that measure estradiol levels.


Q: Is the name 'Kala' a brand name, or is there a generic version available?

The active ingredients in the medication (drospirenone and ethinyl estradiol) are available under various brand names as well as a generic formulation.


Q: Are headaches a frequent side effect of Kala?

Headache is listed in regulatory documents as one of the most common adverse reactions reported by patients using the medication, according to data from clinical trials.


Q: If I have a mild allergic reaction, should I stop taking Kala immediately?

Official patient information indicates that the medication should be stopped immediately, and emergency help should be sought if experiencing signs of a severe allergic reaction, such as trouble breathing, swelling of the face, or hives.


Q: Does Kala interact with alcohol in any way?

Some regulatory-cited information states that the interaction between the medication and alcohol (ethanol) is considered minor, or that there are no known interactions based on clinical studies.


Q: Can people with diabetes use Kala?

While not strictly contraindicated, the medication may adversely affect glucose tolerance (blood sugar levels) and lipid levels. Official labeling indicates that such use may require careful monitoring.


Q: Are there specific instructions for what to do in case of an overdose of Kala?

Regulatory documents include a dedicated Overdosage section. Symptoms reported in cases of overdose include nausea, vomiting, and withdrawal bleeding; no serious ill effects were reported in one key source.


Q: Why is a specific type of patient advised against using Kala?

Patients are advised against using the medication when certain medical conditions are present to mitigate the heightened risk of serious adverse events. These risks primarily involve thromboembolic disorders (blood clots), hyperkalemia (high potassium levels), and certain cancers.


Q: What is the purpose of the initial testing that a doctor does before prescribing Kala?

Before prescribing, a doctor must assess a patient's medical history to check for specific contraindications, such as a history of blood clots or uncontrolled high blood pressure. This initial review is necessary to help determine eligibility and may include a blood pressure check.


Q: Can I crush or split the Kala tablets?

Regulatory-cited patient instructions state that the tablet should be swallowed whole with liquid. Patients are explicitly advised that the tablet should not be broken, crushed, or chewed.


Q: Is Kala usually prescribed alone or in combination with other drugs?

The medication is approved for use as a single hormonal agent (monotherapy) for its approved indications: contraception, PMDD, and acne.


Q: What is the highest dosage of Kala that has been studied in clinical trials?

The approved fixed-dose combination contains 3 mg of drospirenone and 0.02 mg of ethinyl estradiol. Official clinical pharmacology documents note that one component, drospirenone, has had its pharmacokinetics studied following single doses up to 10 mg.


Q: Are there any specific warnings about using Kala before surgery?

Patients are advised to inform their doctor or dentist that they are taking the medication before any kind of surgery or procedure that will require a long period of inactivity. This precaution is due to the potential increased risk of blood clots.


Q: Why is it noted that Kala can sometimes affect the heart rhythm?

The drospirenone component of the medication has activity that can lead to an increase in potassium (hyperkalemia). High potassium levels can cause symptoms such as a slow or irregular heartbeat and, in rare cases, an abnormal heart rhythm.

How should Kala be stored and disposed of?

Kala (drospirenone and ethinyl estradiol) requires specific storage and disposal protocols documented in official regulatory labeling to maintain stability.

Storage Requirements

The tablets must be stored at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F), and should be protected from excessive heat, light, and moisture [1, 2]. The medication must remain in its original container with the lid tightly closed and kept out of the reach and sight of children [1]. The tablet should only be removed from the blister immediately prior to use [3].

Disposal Instructions

Unused or expired tablets should be disposed of using an established drug take-back program or mail-back service [4]. If these are not available, tablets may be mixed with an undesirable substance (e.g., dirt, coffee grounds) in a sealed bag before being placed in household trash [4]. This medication must not be flushed down a toilet or poured down a sink due to potential environmental risk [1, 5].

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

Available in countries:

Equivalent of Kala found in:

A-Z Index: